Vapotherm
Precision Flow Disposable Patient Circuit, High AJ6 (Made in Mexico Medica DPC High) (Customer Facing)
12manufacturers in China registered for this device type
134catalogue numbers in this listing
10510(k) clearances naming this product code
10recalls on this code
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (2), Fujian (1). 9 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 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Jianerkang Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 18 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Betacera Inc. | Suzhou | Jiangsu | Contract manufacturer | 3 |
| Chinamed Products (China) Ltd. | Gaoyao District | Guangdong | Manufacturer | 8 |
| Ninghai Guangjie Electronic Commerce Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 3 |
| Vincent Medical(Dongguan)Technology Company Limited | Dongguan | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Vapotherm Inc., United States |
|---|---|
| FDA product code | BTT |
| Device type | Humidifier, Respiratory Gas, (Direct Patient Interface) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5450 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K111640 |
| Record published | 2020-10-15 |
| Record revised | 2025-04-21 (version 9) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Pack of 3, pack of 5, case of 5, pack of 10, pack of 50, pack of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3000140-BR | In distribution | |
| HVT20-UNIT-VTU-OUS | In distribution | |
| HVT-UKIT-CA | In distribution | |
| HVT-ADPC-HIGH | In distribution | |
| AAA-1 | In distribution | |
| PF-DPC-HIGH | In distribution | |
| PF-DPC-HIGH4 | In distribution | |
| PF-PLUS-IND | In distribution | |
| PF-ADPC-High | In distribution | |
| HPF-TA-22-BR | In distribution | |
| 43000570 | In distribution | |
| PF-WBA-IN | In distribution | |
| HVT-UKIT-NIST | In distribution | |
| PF-PLUS | In distribution | |
| PF-NODPC-HIGH-IN | In distribution | |
| PF-ADPC-LOW-IN | In distribution | |
| HVT-BAT | In distribution | |
| PROSOFT-PED-S-PH | In distribution | |
| PF-DPC-HIGH-AJ5 | In distribution | |
| AAA-1-BR | In distribution | |
| MI1300-PH | In distribution | |
| 3003034-PH | In distribution | |
| HVT-VTU-OUS-BR | In distribution | |
| 43000595 | In distribution | |
| 43000538 | In distribution | |
| PF-DPC-High-WBA | In distribution | |
| PROSOFT-PED-AS-PH | In distribution | |
| AAA-1-IN | In distribution | |
| PF-OAM-NEL-PH | In distribution | |
| HVT-DPC-WBA | In distribution | |
| HVT-UKIT-JP | In distribution | |
| PROSOFT-INF-PH | In distribution | |
| PROSOFT-PRE-PH | In distribution | |
| PF-DPC-High-BR | In distribution | |
| PF-UNIT | In distribution | |
| PF-NODPC-LOW | In distribution | |
| PF-ADPC-HIGH3 | In distribution | |
| 3003011-PH | In distribution | |
| PF-PLUS-IN | In distribution | |
| PF-DPC-Low-BR | In distribution | |
| PF-DPC-LOW2 | In distribution | |
| TA-22-BR | In distribution | |
| PROSOFT-NEO-PH | In distribution | |
| 43000576 | In distribution | |
| PF-DPC-HIGH-BAG-MX | In distribution | |
| HVT-STAND-GCX | In distribution | |
| PF-DPC-HIGH-AJ6 | In distribution | |
| PF-OAMDPC-HIGH | In distribution | |
| PF-ADPC-HIGH4 | In distribution | |
| HVT-VTU-OUS | In distribution | |
| OAM-MAS-UKIT-IN | In distribution | |
| HVT-UKIT-AU | In distribution | |
| PF-NODPC-LOW-BR | In distribution | |
| PF-WBA-PH | In distribution | |
| HVT20-UNIT-FLM | In distribution | |
| PF-NODPC-HIGH-BR | In distribution | |
| HVT20-UNIT-VTU-BR | In distribution | |
| PROSOFT-XL-PH | In distribution | |
| PF-NODPC-HIGH | In distribution | |
| PROSOFT-ADULT-PH | In distribution | |
| PF-NODPC-LOW-IN | In distribution | |
| PF-WBA | In distribution | |
| OAM-NEL-UKIT-PH | In distribution | |
| MN1100A-PH | In distribution | |
| PF-DPC-HIGH-IN | In distribution | |
| 3003034-BR | In distribution | |
| PF-DPC-HIGH-KR | In distribution | |
| PLUS-UKIT-C-JP | In distribution | |
| PROSOFT-INT-INF-PH | In distribution | |
| HVT20-UNIT-VTU-DISS | In distribution | |
| PF-UNIT-FLM-IN | In distribution | |
| HVT20-NEL-FLM | In distribution | |
| PF-DPC-Low-WBA | In distribution | |
| HVT20-STAND | In distribution | |
| HVT-BAT-BR | In distribution | |
| MN1100B-PH | In distribution | |
| SOLO1300-PH | In distribution | |
| 3000138-BR | In distribution | |
| OAM-UKIT-DE | In distribution | |
| PF-DPC-LOW-AK5 | In distribution | |
| PF-DPC-LOW-IN | In distribution | |
| PF-DPC-LOW4 | In distribution | |
| 3003011-BR | In distribution | |
| PF-C-PLUS-FLM | In distribution | |
| MA1700-PH | In distribution | |
| PF-ADPC-LOW4 | In distribution | |
| 43000742 | In distribution | |
| HVT-UKIT-AR | In distribution | |
| HVT-ADPC-LOW | In distribution | |
| PF-STAND-GCX-PH | In distribution | |
| 3101591 | In distribution | |
| HVT-UKIT-DISS-EU | In distribution | |
| PFH-UKIT-ZA | In distribution | |
| 43000208 | In distribution | |
| HVT-STAND-MLN | In distribution | |
| 43000741 | In distribution | |
| PF-DPC-LOW-KR | In distribution | |
| HVT20-MAS-FLM | In distribution | |
| PF-ADPC-LOW3 | In distribution | |
| AAA-1-PH | In distribution | |
| PF-WBA-BR | In distribution | |
| PF-PLUS-PH | In distribution | |
| PF-DPC-LOW | In distribution | |
| OAM-NEL-UKIT-IN | In distribution | |
| HVT-UKIT-US | In distribution | |
| PF-DPC-HIGH2 | In distribution | |
| PLUS-UKIT-C-TW | In distribution | |
| MP1500-PH | In distribution | |
| PF-DPC-HIGH-PH | In distribution | |
| PFH-UNIT | In distribution | |
| HVT-UKIT-IL | In distribution | |
| 3000064-BR | In distribution | |
| PF-OAM-MAS-PH | In distribution | |
| HVT-UKIT-GB | In distribution | |
| PF-DPC-LOW-BAG-MX | In distribution | |
| HVT-UKIT-DE | In distribution | |
| 43000594 | In distribution | |
| PF-ADPC-HIGH-IN | In distribution | |
| HVT-UKIT-BR | In distribution | |
| HVT-DPC-BR | In distribution | |
| OAM-UKIT-IL | In distribution | |
| PF-DPC-LOW3 | In distribution | |
| PF-PLUS-FLM-IN | In distribution | |
| PF-DPC-LOW-PH | In distribution | |
| PF-ADPC-Low | In distribution | |
| OAM-MAS-UKIT-PH | In distribution | |
| HVT-ADPC-WBA | In distribution | |
| PF-DPC-HIGH3 | In distribution | |
| HPF-TA-22 | In distribution | |
| MI1300B-PH | In distribution | |
| OAM-UKIT-US | In distribution | |
| PFH-UKIT-C-ZA | In distribution | |
| MPS1500-PH | In distribution | |
| PF-DPC-LOW-AK6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hudson RCI | Teleflex Medical LLC | 160 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 151 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | Salter Labs | 96 |
| Hudson RCI | Medline Industries, Inc. | 41 |
| AirLife™ | Airlife, Inc. | 27 |
| Fisher and Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 20 |
| F&P Optiflow Junior 2 | Fisher & Paykel Healthcare, Ltd. | 17 |
| MR850 | Fisher & Paykel Healthcare, Ltd. | 13 |
| AirLife | Carefusion | 13 |
| softFlow | TNI Medical AG | 11 |
| F&P Optiflow+ | Fisher & Paykel Healthcare, Ltd. | 7 |
| AnaPod | Westmed, Inc. | 7 |
Showing 12 of 138. All products under Humidifier, Respiratory Gas, (Direct Patient Interface)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K254078 | 2026-04-13 |
| K203357 | 2021-08-25 |
| K191010 | 2019-10-10 |
| K111640 | 2011-10-07 |
| K103316 | 2011-02-08 |
| K072845 | 2008-07-17 |
| K070056 | 2007-04-13 |
| K042245 | 2004-08-30 |
| K013486 | 2003-05-30 |
| K000401 | 2000-08-24 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Vapotherm Inc. | 510(k) number | 2022-12-16 | Class II | Nonconforming Material/Component | There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to excessive rainout. | 5869 total |
Recalls
8 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-08-13 | Class II | Process control | Disposable Patient Circuit that allows water to leak into the center gas lumen | 635 units | 2015-10-02 |
| 2014-08-13 | Class II | Process control | Disposable Patient Circuit that allows water to leak into the center gas lumen | 22828 units | 2015-10-02 |
| 2014-08-13 | Class II | Process control | Disposable Patient Circuit that allows water to leak into the center gas lumen | 22042 units | 2015-10-02 |
| 2014-08-13 | Class II | Process control | Water may leak into the center gas lumen of the Patient Circuit | 207 units | 2015-10-02 |
| 2014-08-13 | Class II | Process control | Disposable Patient Circuit that allows water to leak into the center gas lumen | 865 units | 2015-10-02 |
| 2014-08-13 | Class II | Process control | Disposable Patient Circuit that allows water to leak into the center gas lumen | 1005 units | 2015-10-02 |
| 2014-08-13 | Class II | Process control | Disposable Patient Circuit that allows water to leak into the center gas lumen | 387 units | 2015-10-02 |
| 2014-08-13 | Class II | Process control | Disposable Patient Circuit that allows water to leak into the center gas lumen | 360 units | 2015-10-02 |
| 2005-10-13 | Not classified | Other | A medical device firm changed the labeling of its respiratory gas humidifier by revising the protocol for higher level disinfectants to be used by healthcare practitioners. | 5092 units | 2008-08-28 |
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.