King LTS-D
Ambu / King Ltsd, Size 2.5,W/SUCTION Port, Sterile
84manufacturers in China registered for this device type
7catalogue numbers in this listing
3510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Zhejiang (30), Guangdong (18), Jiangsu (12). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 21 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| IPE Plastic & Hardware Industy, Ltd | Dongguan | Guangdong | Contract manufacturer | 15 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Ningbo Great Mountain Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 12 |
Showing 12 of 84. All 84 manufacturers in China registered for Airway, Oropharyngeal, Anesthesiology
Record
| Listed by | King Systems Corporation., United States |
|---|---|
| FDA product code | CAE |
| Device type | Airway, Oropharyngeal, Anesthesiology |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5110 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-09 |
| Record revised | 2026-01-30 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10, pack of 24 |
| Distribution end date | 2023-08-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KLTSD423 | Adult | In distribution |
| KLTSD425 | Adult | In distribution |
| KLTSD424 | Adult | In distribution |
| KLTSD420 | Pediatric | Withdrawn |
| KLTSD421 | Pediatric | Withdrawn |
| KLTSD4225 | Pediatric | Withdrawn |
| KLTSD422 | Pediatric | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LMA Airway Management | Teleflex Medical LLC | 444 |
| Rusch | Teleflex Medical LLC | 129 |
| SourceMark | Sourcemark, LLC. | 94 |
| Curaplex | Bound Tree Medical, LLC | 86 |
| Hudson RCI | Teleflex Medical LLC | 83 |
| SunMed | SunMed Group Holdings, LLC | 66 |
| Medline | Medline Industries, Inc. | 59 |
| LMA | Teleflex Medical LLC | 50 |
| MediChoice | Owens & Minor Distribution, Inc. | 33 |
| ADC® | American Diagnostic Corp. | 32 |
| Air-Q3® | Airlife, Inc. | 32 |
| Compower | Xiamen Compower Medical Tech. Co., Ltd. | 29 |
Showing 12 of 347. All products under Airway, Oropharyngeal, Anesthesiology
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K033189 | 2004-05-04 |
| K033186 | 2004-04-14 |
| K021634 | 2003-01-09 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| King Systems Corporation. | UDI-DI | 2024-09-26 | Class II | No Marketing Application | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. | |
| King Systems Corporation. | UDI-DI | 2024-09-26 | Class II | No Marketing Application | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. | 21939 units |
Recalls
17 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. 6 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-09-26 | Class II | No Marketing Application | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. | 42605 units | |
| 2024-09-26 | Class II | No Marketing Application | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. | 44755 units | |
| 2024-09-26 | Class II | No Marketing Application | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. | 36727 units | |
| 2024-09-26 | Class II | No Marketing Application | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. | 17925 units | |
| 2024-09-26 | Class II | No Marketing Application | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. | 21591 units | |
| 2024-09-26 | Class II | No Marketing Application | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. | 31457 units | |
| 2019-01-04 | Class II | Packaging process control | Size 0 products were incorrectly packaged and labeled as a size 1 products. | 270 | 2020-04-20 |
| 2013-09-03 | Class III | Labeling mix-ups | Report that size 5 KLTD airways were packaged in pouches indicating a size of 2.5 and shipped to your facility. The correct size of the KLTD airway is clearly marked on the actual airway product and the physical size difference between 2.5 | 9 cases; 45 products | 2014-04-15 |
| 2012-11-02 | Class II | Nonconforming Material/Component | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that ha | 263 cases of product. (2,630 devices) | 2013-05-28 |
| 2012-11-02 | Class II | Nonconforming Material/Component | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that ha | 263 cases of product. (2,630 devices) | 2013-05-28 |
| 2012-11-02 | Class II | Nonconforming Material/Component | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that ha | 263 cases of product. (2,630 devices) | 2013-05-28 |
| 2012-11-02 | Class II | Nonconforming Material/Component | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that ha | 263 cases of product. (2,630 devices) | 2013-05-28 |
| 2012-11-02 | Class II | Nonconforming Material/Component | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that ha | 263 cases of product. (2,630 devices) | 2013-05-28 |
| 2012-11-02 | Class II | Nonconforming Material/Component | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that ha | 263 cases of product. (2,630 devices) | 2013-05-28 |
| 2012-11-02 | Class II | Nonconforming Material/Component | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that ha | 263 cases of product. (2,630 devices) | 2013-05-28 |
| 2012-11-02 | Class II | Nonconforming Material/Component | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that ha | 263 cases of product. (2,630 devices) | 2013-05-28 |
| 2012-11-02 | Class II | Nonconforming Material/Component | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that ha | 263 cases of product. (2,630 devices) | 2013-05-28 |
| 2012-11-02 | Class II | Nonconforming Material/Component | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that ha | 263 cases of product. (2,630 devices) | 2013-05-28 |
| 2011-01-24 | Not classified | Other | The firms contract manufacturer reported that the products were below the specification for hardness. This could contribute to a higher incidence of problems during the insertion and final positioning of the airway in the patient. In rare | 143 cases of 10 each case | 2012-06-29 |
| 2011-01-24 | Not classified | Other | The firms contract manufacturer reported that the products were below the specification for hardness. This could contribute to a higher incidence of problems during the insertion and final positioning of the airway in the patient. In rare | 138 cases 5 units per case, 690 units | 2012-06-29 |
| 2011-01-14 | Not classified | Process control | King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be “inadequately sterilized” and use of this product may result in “patient | 577,426 total units | 2013-02-20 |
| 2011-01-14 | Not classified | Process control | King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be “inadequately sterilized” and use of this product may result in “patient | 577,426 total units | 2013-02-20 |
| 2011-01-14 | Not classified | Process control | King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be “inadequately sterilized” and use of this product may result in “patient | 577,426 total units | 2013-02-20 |
| 2011-01-14 | Not classified | Process control | King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be “inadequately sterilized” and use of this product may result in “patient | 577,426 airway kits total under recall | 2013-02-20 |
| 2011-01-14 | Not classified | Process control | King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be “inadequately sterilized” and use of this product may result in “patient | 2013-02-20 | |
| 2011-01-14 | Not classified | Process control | King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be “inadequately sterilized” and use of this product may result in “patient | 577,426 total units | 2013-02-20 |
| 2011-01-14 | Not classified | Process control | King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be “inadequately sterilized” and use of this product may result in “patient | 577,426 total units | 2013-02-20 |
| 2011-01-14 | Not classified | Process control | King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be “inadequately sterilized” and use of this product may result in “patient | 2013-02-20 | |
| 2011-01-14 | Not classified | Process control | King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be “inadequately sterilized” and use of this product may result in “patient | 2013-02-20 | |
| 2011-01-14 | Not classified | Process control | King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be “inadequately sterilized” and use of this product may result in “patient | 577,426 total units | 2013-02-20 |
| 2011-01-14 | Not classified | Process control | King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be “inadequately sterilized” and use of this product may result in “patient | 2013-02-20 | |
| 2011-01-14 | Not classified | Process control | King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be “inadequately sterilized” and use of this product may result in “patient | 2013-02-20 | |
| 2011-01-14 | Not classified | Process control | King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be “inadequately sterilized” and use of this product may result in “patient | 2013-02-20 | |
| 2011-01-14 | Not classified | Process control | King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be “inadequately sterilized” and use of this product may result in “patient | 577,426 units total | 2013-02-20 |
| 2011-01-14 | Not classified | Process control | King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be “inadequately sterilized” and use of this product may result in “patient | 577,426 total units | 2013-02-20 |
| 2011-01-14 | Not classified | Process control | King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be “inadequately sterilized” and use of this product may result in “patient | 577,426 total units | 2013-02-20 |
| 2011-01-14 | Not classified | Process control | King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be “inadequately sterilized” and use of this product may result in “patient | 577,426 total units | 2013-02-20 |
| 2009-12-15 | Not classified | Labeling False and Misleading | King Systems was issued a warning letter from the Center for Devices and Radiological Health, Office of Compliance on October 28, 2009. The warning letter asserts that Kings Systems KLT(S)-D airway exceeds cleared indications in that it is | 2012-08-16 |
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.