Product code BZH
- Device name
- Meter, Peak Flow, Spirometry
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.1860
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252802 | Peak Flow Meter (PF-10(BR-PEF231)) | Shenzhen Bi-Rich Medical Devices Co., Ltd. | 2026-05-29 |
| K241338 | Peak Flow Meter | Chongqing Moffy Innovation Technology Co., Ltd. | 2024-12-31 |
| K232588 | Aluna 2 | Knox Medical Diagnostics | 2024-11-25 |
| K230423 | Electronic Peak Flow Meter | Taian Dalu Medical Instrument Co., Ltd. | 2024-02-23 |
| K222810 | TD-7301 Peak Flow meter | Gostar Co., Ltd. | 2023-12-19 |
| K203196 | Peak flow meter | Shanghai Sonmol Medical Equipment Co., Ltd. | 2021-05-26 |
| K200832 | Safey Peak Flow Meter | Safey Medical Devices Pvt, Ltd. | 2020-07-30 |
| K193311 | Aluna | Knox Medical Diagnostics, Inc. | 2020-03-25 |
| K191239 | Smart Peak Flow Meter | Guangzhou Homesun Medical Technology Co., Ltd. | 2019-12-06 |
| K180487 | Peak.me | Breathe Me, Ltd. | 2018-10-26 |
| K181666 | Smart One | Mir Medical International Research | 2018-08-01 |
| K172804 | Besmed Peak Flow Meter | Besmed Health Business Corp | 2018-01-11 |
| K170281 | MSA100BT Peak Flow Meter | Beijing M&B Electronic Instruments Co., Ltd. | 2017-10-06 |
| K152276 | Wing Smart FEVI and Peak Flow Meter | Sparo, Inc. | 2016-06-03 |
| K133975 | MSA100 PEAK FLOW METER | Beijing M&B Electronic Instruments Co., Ltd. | 2014-10-03 |
| K123945 | STRIVE DUAL ZONE PEAK FLOW METER | Monaghan Medical Corp. | 2013-04-17 |
| K101380 | RXPEAKFLOW | Noble Marketing | 2010-09-13 |
| K092335 | PEAK EXPIRATORY FLOW METER, KN-9710 | K-Jump Health Co., Ltd. | 2010-04-09 |
| K091412 | CLEAN PEAK FLOW METER | Viasys Healthcare GmbH | 2009-08-21 |
| K082899 | DYNAMIPEAK PEAK FLOW METER | Dynamitech Medical, Inc. | 2009-03-10 |
| K053156 | MINI-WRIGHT DIGITAL, MODEL 3120001 | Clement Clarke Intl., Ltd. | 2006-01-31 |
| K050853 | PMP4 SPIROPRO | Card Guard Scientific Survival , Ltd. | 2005-05-04 |
| K040723 | MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE) | Microlife Intellectual Property GmbH | 2004-06-10 |
| K031024 | MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100 | Microlife Corp. | 2003-11-14 |
| K030586 | MICROPEAK | Micro Direct, Inc. | 2003-08-27 |
| K031514 | MODIFICATION TO TRUPEAK PEAK FLOW METER | Monaghan Medical Corp. | 2003-05-23 |
| K022124 | GALEMED PEAK FLOW METER, MODELS 3751/3752 | Galemed Corp. | 2003-04-03 |
| K023097 | TRUEZONE PEAK FLOW METER | Monaghan Medical Corp. | 2003-03-07 |
| K013489 | KP + LFM | Pds Healthcare Products, Inc. | 2001-11-29 |
| K010009 | KOKO PEAK KP; KOKO PEAK KP+ | Pds Healthcare Products, Inc. | 2001-06-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00816042015052 | FORA | FORA CARE INC. | 2026-05-18 |
| 00816042015045 | FORA | FORA CARE INC. | 2026-05-18 |
| 10193489149722 | HUDSON RCI | MEDLINE INDUSTRIES, INC. | 2024-02-07 |
| 00311917034980 | Walgreens | WALGREEN CO. | 2023-08-21 |
| G004TCPFMA10 | Tenovi | Tenovi Co. | 2022-11-01 |
| 00642632732050 | microlife | MICROLIFE USA, INC. | 2022-06-02 |
| 00810025922276 | caring mill | Caring Mill | 2021-06-09 |
| 00840117319042 | Resp-O2 Peak Flow Meter Full Range 50-800 L/min | Dynarex Corporation | 2021-04-22 |
| 00840117319035 | Resp-O2 Peak Flow Meter Low Range 50-300 L/min | Dynarex Corporation | 2021-04-22 |
| 10884389144558 | Medline | MEDLINE INDUSTRIES, INC. | 2021-04-01 |
| 14026704639745 | HUDSON RCI | TELEFLEX INCORPORATED | 2019-02-12 |
| 00812574025422 | Curaplex | TRI-ANIM HEALTH SERVICES, INC. | 2017-12-22 |
| 00642632732005 | microlife | MICROLIFE USA, INC. | 2017-05-19 |
| 15099169635200 | Micro | VITALOGRAPH (IRELAND) LIMITED | 2017-02-21 |
| 00812574026214 | Curaplex | TRI-ANIM HEALTH SERVICES, INC. | 2017-02-06 |
| 00857818006010 | AsthmaMD | GENIA MEDICAL, INC. | 2016-12-16 |
| 05099169437036 | PFM | VITALOGRAPH (IRELAND) LIMITED | 2016-12-01 |
| 05099169436022 | PFM | VITALOGRAPH (IRELAND) LIMITED | 2016-12-01 |
| 05099169434004 | PFM | VITALOGRAPH (IRELAND) LIMITED | 2016-12-01 |
| 05099169430006 | PFM | VITALOGRAPH (IRELAND) LIMITED | 2016-12-01 |
| 00855784004016 | SpiroFlow | Spirometrics | 2016-10-11 |
| 00855784004047 | SpiroFlow | Spirometrics | 2016-10-11 |
| 00604351965102 | TruZone® | Monaghan Medical Corporation | 2016-09-26 |
| 10885403174827 | AirLife | Carefusion Corporation | 2016-09-21 |
| 10852417003207 | Hudson RCI | NSPIRE HEALTH, INC. | 2016-09-20 |
| 00604351915107 | TruPeak® | Monaghan Medical Corporation | 2016-09-19 |
| 00604351915015 | TruPeak® | Monaghan Medical Corporation | 2016-09-19 |
| 00822383539423 | Drive | Drive Devilbiss Healthcare | 2016-09-16 |
| 24710810084601 | N/A | GALEMED CORPORATION | 2015-10-15 |
| 24710810083031 | N/A | GALEMED CORPORATION | 2015-10-15 |