Meter, Peak Flow, Spirometry
FDA product code BZH · Class II (moderate risk) · 21 CFR 868.1860 · Anesthesiology
81510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Monaghan Medical Corp. 10
- Clement Clarke Intl., Ltd. 4
- Health Products, Inc. 3
- Enact Health Management Systems 3
- Vitalograph , Ltd. 3
- Healthscan Products, Inc. 3
- Projects IN Health 2
- Biotrine Corp. 2
- Harwill Medical (Pty) , Ltd. 2
- Card Guard Scientific Survival , Ltd. 2
- Knox Medical Diagnostics 2
- Pds Healthcare Products, Inc. 2
- Clement Clarke, Inc. 2
- Beijing M&B Electronic Instruments Co., Ltd. 2
- Microlife Corp. 2
- Healthdyne, Inc. 1
- International Electronic Technology Corp. 1
- Ferraris Medical, Inc. 1
- Shenzhen Bi-Rich Medical Devices Co., Ltd. 1
- Spirometrics, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253180 | Microlife Digital Peak Flow Meter, Model PF200B (PF200B)BZH · Traditional | Microlife Corporation | 06/23/2026SE |
| K252802 | Peak Flow Meter (PF-10(BR-PEF231))BZH · Traditional | Shenzhen Bi-Rich Medical Devices Co., Ltd. | 05/29/2026SE |
| K241338 | Peak Flow MeterBZH · Traditional | Chongqing Moffy Innovation Technology Co., Ltd. | 12/31/2024SE |
| K232588 | Aluna 2BZH · Traditional | Knox Medical Diagnostics | 11/25/2024SE |
| K230423 | Electronic Peak Flow MeterBZH · Traditional | Taian Dalu Medical Instrument Co., Ltd. | 02/23/2024SE |
| K222810 | TD-7301 Peak Flow meterBZH · Traditional | Gostar Co., Ltd. | 12/19/2023SE |
| K203196 | Peak flow meterBZH · Traditional | Shanghai Sonmol Medical Equipment Co., Ltd. | 05/26/2021SE |
| K200832 | Safey Peak Flow MeterBZH · Traditional | Safey Medical Devices Pvt, Ltd. | 07/30/2020SE |
| K193311 | AlunaBZH · Traditional | Knox Medical Diagnostics, Inc. | 03/25/2020SE |
| K191239 | Smart Peak Flow MeterBZH · Traditional | Guangzhou Homesun Medical Technology Co., Ltd. | 12/06/2019SE |
| K180487 | Peak.meBZH · Traditional | Breathe Me, Ltd. | 10/26/2018SE |
| K181666 | Smart OneBZH · Traditional | Mir Medical International Research | 08/01/2018SE |
| K172804 | Besmed Peak Flow MeterBZH · Traditional | Besmed Health Business Corp | 01/11/2018SE |
| K170281 | MSA100BT Peak Flow MeterBZH · Traditional | Beijing M&B Electronic Instruments Co., Ltd. | 10/06/2017SE |
| K152276 | Wing Smart FEVI and Peak Flow MeterBZH · Traditional | Sparo, Inc. | 06/03/2016SE |
| K133975 | MSA100 Peak Flow MeterBZH · Traditional | Beijing M&B Electronic Instruments Co., Ltd. | 10/03/2014SE |
| K123945 | Strive Dual Zone Peak Flow MeterBZH · Traditional | Monaghan Medical Corp. | 04/17/2013SE |
| K101380 | RxpeakflowBZH · Traditional | Noble Marketing | 09/13/2010SE |
| K092335 | Peak Expiratory Flow Meter, KN-9710BZH · Traditional | K-Jump Health Co., Ltd. | 04/09/2010SE |
| K091412 | Clean Peak Flow MeterBZH · Special | Viasys Healthcare GmbH | 08/21/2009SE |
| K082899 | Dynamipeak Peak Flow MeterBZH · Traditional | Dynamitech Medical, Inc. | 03/10/2009SE |
| K053156 | Mini-Wright Digital, Model 3120001BZH · Traditional | Clement Clarke Intl., Ltd. | 01/31/2006SE |
| K050853 | PMP4 SpiroproBZH · Special | Card Guard Scientific Survival , Ltd. | 05/04/2005SE |
| K040723 | Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and PF-100-1…BZH · Abbreviated | Microlife Intellectual Property GmbH | 06/10/2004SE |
| K031024 | Microlife Electronic Peak Flow Monitor, Model PF-100BZH · Traditional | Microlife Corp. | 11/14/2003SE |
| K030586 | MicropeakBZH · Traditional | Micro Direct, Inc. | 08/27/2003SE |
| K031514 | Modification to Trupeak Peak Flow MeterBZH · Special | Monaghan Medical Corp. | 05/23/2003SE |
| K022124 | Galemed Peak Flow Meter, Models 3751/3752BZH · Traditional | Galemed Corp. | 04/03/2003SE |
| K023097 | Truezone Peak Flow MeterBZH · Abbreviated | Monaghan Medical Corp. | 03/07/2003SE |
| K013489 | KP + LFMBZH · Traditional | Pds Healthcare Products, Inc. | 11/29/2001SE |
| K010009 | Koko Peak KP; Koko Peak Kp+BZH · Abbreviated | Pds Healthcare Products, Inc. | 06/01/2001SE |
| K980951 | OneflowBZH · Traditional | Sti Medical | 02/25/2000SE |
| K991412 | Vitalograph MicroBZH · Traditional | Vitalograph, Inc. | 02/04/2000SE |
| K992618 | RespalertBZH · Traditional | Harwill Medical (Pty) , Ltd. | 10/29/1999SE |
| K991212 | Modification to Truzone Peak Flow MeterBZH · Abbreviated | Monaghan Medical Corp. | 07/01/1999SE |
| K982334 | Airzone Peak FlowmeterBZH · Traditional | Clement Clarke Intl., Ltd. | 01/14/1999SE |
| K982995 | Accutrax, Model EPF840BZH · Traditional | Korr Medical Technologies, Inc. | 12/04/1998SE |
| K982676 | Airwatch II ZoneBZH · Traditional | Enact Health Management Systems | 10/29/1998SE |
| K982675 | Airwatch II ZonelessBZH · Traditional | Enact Health Management Systems | 10/29/1998SE |
| K980550 | Whistle WatchBZH · Traditional | Harwill Medical (Pty) , Ltd. | 08/27/1998SE |
| K980960 | In-Check Inspiratory FlowmeterBZH · Traditional | Clement Clarke Intl., Ltd. | 06/10/1998SE |
| K980443 | Peak Flow Meter MinimaxBZH · Traditional | The D&T, Inc. | 04/30/1998SE |
| K970507 | Peak Flow MeterBZH · Traditional | Intl. Medical, Inc. | 06/13/1997SE |
| K961779 | Mini-Bell Peak Flow Meter/Low Range Model Peak Flow MeterBZH · Traditional | Avion Medical Products, Inc. | 06/13/1997SE |
| K964130 | Aerogear Asthma Action KitBZH · Traditional | Monaghan Medical Corp. | 01/10/1997SE |
| K962074 | VM Plus Peak FlowmeterBZH · Traditional | Clement Clarke Intl., Ltd. | 01/02/1997SE |
| K963089 | Truzone Peak Flow MeterBZH · Traditional | Monaghan Medical Corp. | 11/06/1996SE |
| K963095 | Trupeak Peak Flow MeterBZH · Traditional | Monaghan Medical Corp. | 11/04/1996SE |
| K962924 | Personal Best II with Zone Management SystemBZH · Traditional | Healthscan Products, Inc. | 10/25/1996SE |
| K962929 | Personal Best IIBZH · Traditional | Healthscan Products, Inc. | 10/24/1996SE |
| K953411 | Breath-Taker Breath-AlertBZH · Traditional | Roxon - Universal Medical , Ltd. | 06/13/1996SE |
| K952909 | AutozoneBZH · Traditional | Health Scan, Inc. | 03/29/1996SE |
| K952713 | Mini Wright LR AfsBZH · Traditional | Clement Clarke, Inc. | 03/29/1996SE |
| K955234 | Trupeak Peak Flow MeterBZH · Traditional | Monaghan Medical Corp. | 03/18/1996SE |
| K955262 | Truzone Peak Flow MeterBZH · Traditional | Monaghan Medical Corp. | 03/07/1996SE |
| K954277 | Astech Peak Flow MeterBZH · Traditional | Center Laboratories, Inc. | 02/21/1996SE |
| K943678 | Electronic Flow MeterBZH · Traditional | Vitalograph, Inc. | 12/14/1995SE |
| K953458 | Rainbow Step Up Systems Inc. Asthma Home Care PlanBZH · Traditional | Raiinbow Step UP Systems, Inc. | 11/17/1995SESK |
| K934795 | Card GuardBZH · Traditional | Card Guard Scientific Survival , Ltd. | 04/14/1995SE |
| K936110 | AspireBZH · Traditional | Dura Pharmaceuticals, Inc. | 03/23/1995SE |
| K941226 | Airwatch MonitorBZH · Traditional | Enact Health Management Systems | 11/16/1994SE |
| K940836 | Peaklog and Display SoftwareBZH · Traditional | Tamarac Systems Corp. | 11/01/1994SE |
| K940835 | Peaklog and Display SoftwareBZH · Traditional | Medtrac Technologies Corp. | 11/01/1994SE |
| K924322 | Flow=MedBZH · Traditional | International Electronic Technology Corp. | 04/26/1994SE |
| K934502 | Flow SpirometerBZH · Traditional | Healthdyne, Inc. | 04/04/1994SE |
| K933889 | Personal Best Low RangeBZH · Traditional | Healthscan Products, Inc. | 09/09/1993SE |
| K926307 | Peak Flow MeterBZH · Traditional | Monaghan Medical Corp. | 07/22/1993SE |
| K924343 | Wright Pocket Peak Flow MeterBZH · Traditional | Ferraris Medical, Inc. | 06/16/1993SE |
| K914126 | VMX Mini-Log FlowmeterBZH · Traditional | Clement Clarke, Inc. | 03/05/1993SE |
| K920390 | The PeakBZH · Traditional | Multispiro, Inc. | 09/11/1992SE |
| K915060 | Astech Home Peak Flow MeterBZH · Traditional | Biotrine Corp. | 09/11/1992SE |
| K912866 | Peak Expiratory Flow MeterBZH · Traditional | Health Products, Inc. | 08/13/1992SE |
| K915059 | Peak Flow MonitorBZH · Traditional | Spirometrics, Inc. | 07/27/1992SE |
| K902292 | Modified Assess(R) Peak Flow MeterBZH · Traditional | Health Products, Inc. | 08/10/1990SE |
| K896953 | Modified Assess(R) Peak Flow MeterBZH · Traditional | Health Products, Inc. | 01/30/1990SE |
| K853922 | Plotter for AS-500BZH · Traditional | Riko Medical & Scientific Instrument Corp. | 11/14/1985SE |
| K851265 | Peak Flowmeters for SpirometryBZH · Traditional | Solcoor, Inc. | 10/29/1985SE |
| K813414 | Peak Flow MonitorBZH · Traditional | Biotrine Corp. | 12/31/1981SE |
| K781922 | Pulmonary MonitorBZH · Traditional | Vitalograph , Ltd. | 02/13/1979SE |
| K781224 | Meter, Flow, PeakBZH · Traditional | Projects IN Health | 10/15/1978SE |
| K770580 | Peak Flow MeterBZH · Traditional | Projects IN Health | 08/04/1977SE |