BZH
81 FDA 510(k) clearances · Product code
184 daysmedian time to decision
412 days90th percentile
81clearances measured
FDA profile
- Official device name
- Meter, Peak Flow, Spirometry
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1860
- Medical specialty
- Anesthesiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1994: 1 · 1995: 2 · 1999: 1 · 2003: 1 · 2004: 1 · 2014: 22
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Microlife Digital Peak Flow Meter, Model PF200B (PF200B) (K253180) | Microlife Corporation | 2026-06-23 |
| Peak Flow Meter (PF-10(BR-PEF231)) (K252802) | Shenzhen Bi-Rich Medical Devices Co., Ltd. | 2026-05-29 |
| Peak Flow Meter (K241338) | Chongqing Moffy Innovation Technology Co., Ltd. | 2024-12-31 |
| Aluna 2 (K232588) | Knox Medical Diagnostics | 2024-11-25 |
| Electronic Peak Flow Meter (K230423) | Taian Dalu Medical Instrument Co., Ltd. | 2024-02-23 |
| TD-7301 Peak Flow meter (K222810) | Gostar Co., Ltd. | 2023-12-19 |
| Peak flow meter (K203196) | Shanghai Sonmol Medical Equipment Co., Ltd. | 2021-05-26 |
| Safey Peak Flow Meter (K200832) | Safey Medical Devices Pvt, Ltd. | 2020-07-30 |
| Aluna (K193311) | Knox Medical Diagnostics, Inc. | 2020-03-25 |
| Smart Peak Flow Meter (K191239) | Guangzhou Homesun Medical Technology Co., Ltd. | 2019-12-06 |
| Peak.me (K180487) | Breathe Me, Ltd. | 2018-10-26 |
| Smart One (K181666) | Mir Medical International Research | 2018-08-01 |
| Besmed Peak Flow Meter (K172804) | Besmed Health Business Corp | 2018-01-11 |
| MSA100BT Peak Flow Meter (K170281) | Beijing M&B Electronic Instruments Co., Ltd. | 2017-10-06 |
| Wing Smart FEVI and Peak Flow Meter (K152276) | Sparo, Inc. | 2016-06-03 |
| MSA100 PEAK FLOW METER (K133975) | Beijing M&B Electronic Instruments Co., Ltd. | 2014-10-03 |
| STRIVE DUAL ZONE PEAK FLOW METER (K123945) | Monaghan Medical Corp. | 2013-04-17 |
| RXPEAKFLOW (K101380) | Noble Marketing | 2010-09-13 |
| PEAK EXPIRATORY FLOW METER, KN-9710 (K092335) | K-Jump Health Co., Ltd. | 2010-04-09 |
| CLEAN PEAK FLOW METER (K091412) | Viasys Healthcare GmbH | 2009-08-21 |
| DYNAMIPEAK PEAK FLOW METER (K082899) | Dynamitech Medical, Inc. | 2009-03-10 |
| MINI-WRIGHT DIGITAL, MODEL 3120001 (K053156) | Clement Clarke Intl., Ltd. | 2006-01-31 |
| PMP4 SPIROPRO (K050853) | Card Guard Scientific Survival , Ltd. | 2005-05-04 |
| MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE) (K040723) | Microlife Intellectual Property GmbH | 2004-06-10 |
| MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100 (K031024) | Microlife Corp. | 2003-11-14 |
| MICROPEAK (K030586) | Micro Direct, Inc. | 2003-08-27 |
| MODIFICATION TO TRUPEAK PEAK FLOW METER (K031514) | Monaghan Medical Corp. | 2003-05-23 |
| GALEMED PEAK FLOW METER, MODELS 3751/3752 (K022124) | Galemed Corp. | 2003-04-03 |
| TRUEZONE PEAK FLOW METER (K023097) | Monaghan Medical Corp. | 2003-03-07 |
| KP + LFM (K013489) | Pds Healthcare Products, Inc. | 2001-11-29 |
| KOKO PEAK KP; KOKO PEAK KP+ (K010009) | Pds Healthcare Products, Inc. | 2001-06-01 |
| ONEFLOW (K980951) | Sti Medical | 2000-02-25 |
| VITALOGRAPH MICRO (K991412) | Vitalograph, Inc. | 2000-02-04 |
| RESPALERT (K992618) | Harwill Medical (Pty) , Ltd. | 1999-10-29 |
| MODIFICATION TO TRUZONE PEAK FLOW METER (K991212) | Monaghan Medical Corp. | 1999-07-01 |
| AIRZONE PEAK FLOWMETER (K982334) | Clement Clarke Intl., Ltd. | 1999-01-14 |
| ACCUTRAX, MODEL EPF840 (K982995) | Korr Medical Technologies, Inc. | 1998-12-04 |
| AIRWATCH II ZONE (K982676) | Enact Health Management Systems | 1998-10-29 |
| AIRWATCH II ZONELESS (K982675) | Enact Health Management Systems | 1998-10-29 |
| WHISTLE WATCH (K980550) | Harwill Medical (Pty) , Ltd. | 1998-08-27 |
| IN-CHECK INSPIRATORY FLOWMETER (K980960) | Clement Clarke Intl., Ltd. | 1998-06-10 |
| PEAK FLOW METER MINIMAX (K980443) | The D&T, Inc. | 1998-04-30 |
| PEAK FLOW METER (K970507) | Intl. Medical, Inc. | 1997-06-13 |
| MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER (K961779) | Avion Medical Products, Inc. | 1997-06-13 |
| AEROGEAR ASTHMA ACTION KIT (K964130) | Monaghan Medical Corp. | 1997-01-10 |
| VM PLUS PEAK FLOWMETER (K962074) | Clement Clarke Intl., Ltd. | 1997-01-02 |
| TRUZONE PEAK FLOW METER (K963089) | Monaghan Medical Corp. | 1996-11-06 |
| TRUPEAK PEAK FLOW METER (K963095) | Monaghan Medical Corp. | 1996-11-04 |
| PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM (K962924) | Healthscan Products, Inc. | 1996-10-25 |
| PERSONAL BEST II (K962929) | Healthscan Products, Inc. | 1996-10-24 |
| BREATH-TAKER BREATH-ALERT (K953411) | Roxon - Universal Medical , Ltd. | 1996-06-13 |
| MINI WRIGHT LR AFS (K952713) | Clement Clarke, Inc. | 1996-03-29 |
| AUTOZONE (K952909) | Health Scan, Inc. | 1996-03-29 |
| TRUPEAK PEAK FLOW METER (K955234) | Monaghan Medical Corp. | 1996-03-18 |
| TRUZONE PEAK FLOW METER (K955262) | Monaghan Medical Corp. | 1996-03-07 |
| ASTECH PEAK FLOW METER (K954277) | Center Laboratories, Inc. | 1996-02-21 |
| ELECTRONIC FLOW METER (K943678) | Vitalograph, Inc. | 1995-12-14 |
| RAINBOW STEP UP SYSTEMS INC. ASTHMA HOME CARE PLAN (K953458) | Raiinbow Step UP Systems, Inc. | 1995-11-17 |
| CARD GUARD (K934795) | Card Guard Scientific Survival , Ltd. | 1995-04-14 |
| ASPIRE (K936110) | Dura Pharmaceuticals, Inc. | 1995-03-23 |
| AIRWATCH MONITOR (K941226) | Enact Health Management Systems | 1994-11-16 |
| PEAKLOG AND DISPLAY SOFTWARE (K940836) | Tamarac Systems Corp. | 1994-11-01 |
| PEAKLOG AND DISPLAY SOFTWARE (K940835) | Medtrac Technologies Corp. | 1994-11-01 |
| FLOW=MED (K924322) | International Electronic Technology Corp. | 1994-04-26 |
| FLOW SPIROMETER (K934502) | Healthdyne, Inc. | 1994-04-04 |
| PERSONAL BEST LOW RANGE (K933889) | Healthscan Products, Inc. | 1993-09-09 |
| PEAK FLOW METER (K926307) | Monaghan Medical Corp. | 1993-07-22 |
| WRIGHT POCKET PEAK FLOW METER (K924343) | Ferraris Medical, Inc. | 1993-06-16 |
| VMX MINI-LOG FLOWMETER (K914126) | Clement Clarke, Inc. | 1993-03-05 |
| ASTECH HOME PEAK FLOW METER (K915060) | Biotrine Corp. | 1992-09-11 |
| THE PEAK (K920390) | Multispiro, Inc. | 1992-09-11 |
| PEAK EXPIRATORY FLOW METER (K912866) | Health Products, Inc. | 1992-08-13 |
| PEAK FLOW MONITOR (K915059) | Spirometrics, Inc. | 1992-07-27 |
| MODIFIED ASSESS(R) PEAK FLOW METER (K902292) | Health Products, Inc. | 1990-08-10 |
| MODIFIED ASSESS(R) PEAK FLOW METER (K896953) | Health Products, Inc. | 1990-01-30 |
| PLOTTER FOR AS-500 (K853922) | Riko Medical & Scientific Instrument Corp. | 1985-11-14 |
| PEAK FLOWMETERS FOR SPIROMETRY (K851265) | Solcoor, Inc. | 1985-10-29 |
| PEAK FLOW MONITOR (K813414) | Biotrine Corp. | 1981-12-31 |
| PULMONARY MONITOR (K781922) | Vitalograph , Ltd. | 1979-02-13 |
| METER, FLOW, PEAK (K781224) | Projects IN Health | 1978-10-15 |
| PEAK FLOW METER (K770580) | Projects IN Health | 1977-08-04 |
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