Universal F® FLEX2®
UNIVERSAL F FLEX2 CIRCUIT & Pack Kit
55manufacturers in China registered for this device type
55catalogue numbers in this listing
2510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Zhejiang (18), Guangdong (18), Jiangsu (5). 18 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 21 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| Ningbo Great Mountain Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 12 |
| Ningbo Shengyurui Medical Appliance Co. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Flying Tooling Engineering Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Hangzhou Formed Medical Devices Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 9 |
Showing 12 of 55. All 55 manufacturers in China registered for Circuit, Breathing (W Connector, Adaptor, Y Piece)
Record
| Listed by | King Systems Corporation., United States |
|---|---|
| FDA product code | CAI |
| Device type | Circuit, Breathing (W Connector, Adaptor, Y Piece) |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5240 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-13 |
| Record revised | 2026-01-30 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 40, pack of 30 |
| Sizes | Outer diameter 5 mm; length 350 mm; lumen/inner diameter 2 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AF070-6121 | Adult | In distribution |
| AF470-61Z | Adult / Pediatric | In distribution |
| AF370-176Z | Adult | In distribution |
| KNAF4116-6121Z | Adult | In distribution |
| AF470-6121Z | Adult / Pediatric | In distribution |
| AF4116-6121Z | Adult | In distribution |
| AF370-6121Z | Adult | In distribution |
| AF370-17621Z | Adult | In distribution |
| AF376-6121Z | Adult | In distribution |
| AF475-17621Z | Adult / Pediatric | In distribution |
| JAF370-6121Z | Adult | In distribution |
| KNAFP170-6121 | Adult | In distribution |
| AF370-61Z | Adult | In distribution |
| AF3110-61Z | Adult | In distribution |
| KNAF376-6121Z | Adult | In distribution |
| F22001 | Length 350 mm | In distribution |
| AF3116-176Z | Adult | In distribution |
| KNAF375-6121Z | Adult | In distribution |
| AF375-61Z | Adult | In distribution |
| AF3110-176Z | Adult | In distribution |
| AF3115-6121Z | Adult | In distribution |
| JAF3116-6121Z | Adult | In distribution |
| JAF3115-61Z | Adult | In distribution |
| AF0110-6121 | Adult / Pediatric | In distribution |
| JAF376-6121Z | Adult | In distribution |
| AF3110-17621Z | Adult | In distribution |
| AF3116-618Z | Adult | In distribution |
| AF1110-6121Z | Pediatric | In distribution |
| KNAF476-6121Z | Adult / Pediatric | In distribution |
| AF375-17621Z | Adult | In distribution |
| KNAF270-6121Z | Lumen/Inner Diameter 2 mm | In distribution |
| AF3115-61Z | Adult | In distribution |
| AF4110-6121Z | Adult | In distribution |
| AF170-6121Z | Pediatric | In distribution |
| NAF376-6121Z | Adult | In distribution |
| NAF3116-6121Z | Adult | In distribution |
| AF476-6121Z | Adult / Pediatric | In distribution |
| AF470-17621Z | Adult / Pediatric | In distribution |
| AF476-17621Z | Adult / Pediatric | In distribution |
| KNAF3116-6121Z | Adult | In distribution |
| AF3116-6121Z | Adult | In distribution |
| KNAF3115-6121Z | Adult | In distribution |
| AF376-6127Z | Adult | In distribution |
| AF376-618Z | Adult | In distribution |
| AF3115-17621Z | Adult | In distribution |
| AF376-17621Z | Adult | In distribution |
| AF475-6121Z | Adult / Pediatric | In distribution |
| JAF476-6121Z | Adult / Pediatric | In distribution |
| AF376-176Z | Adult | In distribution |
| AF3116-17621Z | Adult | In distribution |
| JAF375-6121Z | Adult | In distribution |
| SJDF3115-6121Z | Pediatric | In distribution |
| AF475-61Z | Adult / Pediatric | In distribution |
| KNUF3115-6121Z | Length 350 mm | In distribution |
| AF375-6121Z | Adult | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 3,457 |
| Vital Signs™ | Airlife, Inc. | 1,018 |
| Hudson RCI | Teleflex Medical LLC | 176 |
| Vital Signs™ | AirLife Finland Oy | 143 |
| Universal F2®ANESTHESIA Breathing Circuit | King Systems Corporation. | 133 |
| Universal FLEX2®BREATHING Circuit | King Systems Corporation. | 123 |
| Adult Ultra Flex®anesthesia Breathing Circuit | King Systems Corporation. | 111 |
| Portex | ICU Medical, Inc | 95 |
| AincA® | Anesthesia Associates, Inc. | 76 |
| Medline/MMS Sales | Medline Industries, Inc. | 73 |
| Pediatric Ultra Flex®anesthesia Breathing Circuit | King Systems Corporation. | 71 |
| Vital Signs™ | Vyaire Medical, Inc. | 70 |
Showing 12 of 522. All products under Circuit, Breathing (W Connector, Adaptor, Y Piece)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K922789 | 1993-05-26 |
| K880683 | 1988-03-09 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-08-23 | Class I | Labeling mix-ups | King Systems received a customer complaint indicating that the customer had ordered a breathing circuit with a Latex breathing bag. The product they received contained a Latex breathing bag, but was labeled as non-latex. | 1 case; 40 units | 2013-11-18 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
| 2008-08-01 | Not classified | Pending | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | Approx. 500,000 units of all products. | 2009-11-12 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.