F&P 850
F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
12manufacturers in China registered for this device type
4catalogue numbers in this listing
28510(k) clearances naming this product code
8recalls 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 | Fisher & Paykel Healthcare, Ltd., New Zealand |
|---|---|
| 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, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2026-04-13 |
| Record revised | 2026-04-13 (version 6) |
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, manufacturing date |
| Storage | Storage environment temperature -10 to 50 °C |
| Packaging | Pack of 40, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 850A61J | In distribution | ||
| MR290V | In distribution | ||
| MR290VX | 10 | In distribution | |
| MR290HFV | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hudson RCI | Teleflex Medical LLC | 160 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 151 |
| Vapotherm | Vapotherm Inc. | 134 |
| 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 |
Showing 12 of 138. All products under Humidifier, Respiratory Gas, (Direct Patient Interface)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253479 | 2025-12-19 |
| K251611 | 2025-06-25 |
| K234058 | 2024-08-08 |
| K233821 | 2024-06-13 |
| K222292 | 2024-05-08 |
| K231956 | 2024-02-07 |
| K223684 | 2023-09-05 |
| K220703 | 2023-06-16 |
| K222197 | 2023-04-06 |
| K212031 | 2022-04-22 |
| K211096 | 2022-01-28 |
| K201723 | 2021-03-16 |
| K191818 | 2020-03-19 |
| K162553 | 2018-12-20 |
| K143646 | 2015-03-05 |
| K132017 | 2014-03-25 |
| K131957 | 2013-12-04 |
| K131895 | 2013-10-24 |
| K121975 | 2013-01-03 |
| K110019 | 2012-03-30 |
| K100554 | 2010-05-28 |
| K092846 | 2010-01-27 |
| K073706 | 2008-03-31 |
| K033710 | 2004-04-13 |
| K020332 | 2003-07-07 |
| K003973 | 2001-06-01 |
| K983112 | 1998-11-10 |
| K881970 | 1989-03-09 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2025-09-18 | Class II | Nonconforming Material/Component | When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120 seconds, which may delay user awareness to reconnect power, | 51,144 | |
| 2024-04-02 | Class II | Nonconforming Material/Component | Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, intermittent or inaudible alarm sound levels. In the absence of an | 7,147 | |
| 2008-10-22 | Not classified | Process change control | The recall was initiated because certain lot dates of the RT240 Adult Breathing Circuit Kits manufactured on or before June 27, 2008 include a heated breathing circuit that may be more susceptible to damage when used in excess of the specif | 229,320 units | 2012-03-26 |
| 2005-12-20 | Not classified | Other | Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire. | 341boxes (3,410 pcs) | 2012-04-19 |
| 2005-12-20 | Not classified | Other | Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire. | 2175 boxes (21,750 pcs) | 2012-04-19 |
| 2005-12-20 | Not classified | Other | Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire. | 260 boxes (2,600 pcs) | 2012-04-19 |
| 2005-12-20 | Not classified | Other | Risk of fire. The manufacturing process may have the potential to damage the insulation of the heater wire in circuits within the specified lot range. This may lead to a potential risk of fire. | 2699 boxes (26,990 pcs) | 2012-04-19 |
| 2004-12-21 | Not classified | Other | Pressure elbow may be partly occluded. | 2200 | 2005-11-21 |
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.