BZH · Class II · 21 CFR 868.1860

FDA Product Code BZH: Meter, Peak Flow, Spirometry

Leading manufacturers include Monaghan Medical Corp., Clement Clarke Intl., Ltd. and Harwill Medical (Pty) , Ltd..

81
Total
81
Cleared
205d
Avg days
1977
Since
Growing category - 4 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 307d recently vs 200d historically

FDA 510(k) Cleared Meter, Peak Flow, Spirometry Devices (Product Code BZH)

81 devices
1–24 of 81
Cleared Jun 23, 2026
Microlife Digital Peak Flow Meter, Model PF200B (PF200B)
K253180
Microlife Corporation
Anesthesiology · 270d
Cleared May 29, 2026
Peak Flow Meter (PF-10(BR-PEF231))
K252802
Shenzhen Bi-Rich Medical Devices Co., Ltd.
Anesthesiology · 268d
Cleared Dec 31, 2024
Peak Flow Meter
K241338
Chongqing Moffy Innovation Technology Co., Ltd.
Anesthesiology · 232d
Cleared Nov 25, 2024
Aluna 2
K232588
Knox Medical Diagnostics
Anesthesiology · 458d
Cleared Feb 23, 2024
Electronic Peak Flow Meter
K230423
Taian Dalu Medical Instrument Co., Ltd.
Anesthesiology · 371d
Cleared Dec 19, 2023
TD-7301 Peak Flow meter
K222810
Gostar Co., Ltd.
Anesthesiology · 459d
Cleared May 26, 2021
Peak flow meter
K203196
Shanghai Sonmol Medical Equipment Co., Ltd.
Anesthesiology · 210d
Cleared Jul 30, 2020
Safey Peak Flow Meter
K200832
Safey Medical Devices Pvt, Ltd.
Anesthesiology · 122d
Cleared Mar 25, 2020
Aluna
K193311
Knox Medical Diagnostics, Inc.
Anesthesiology · 117d
Cleared Dec 06, 2019
Smart Peak Flow Meter
K191239
Guangzhou Homesun Medical Technology Co., Ltd.
Anesthesiology · 212d
Cleared Oct 26, 2018
Peak.me
K180487
Breathe Me, Ltd.
Anesthesiology · 245d
Cleared Aug 01, 2018
Smart One
K181666
Mir Medical International Research
Anesthesiology · 37d
Cleared Jan 11, 2018
Besmed Peak Flow Meter
K172804
Besmed Health Business Corp
Anesthesiology · 115d
Cleared Oct 06, 2017
MSA100BT Peak Flow Meter
K170281
Beijing M&B Electronic Instruments Co., Ltd.
Anesthesiology · 249d
Cleared Jun 03, 2016
Wing Smart FEVI and Peak Flow Meter
K152276
Sparo, Inc.
Anesthesiology · 296d
Cleared Oct 03, 2014
MSA100 PEAK FLOW METER
K133975
Beijing M&B Electronic Instruments Co., Ltd.
Anesthesiology · 281d
Cleared Apr 17, 2013
STRIVE DUAL ZONE PEAK FLOW METER
K123945
Monaghan Medical Corp.
Anesthesiology · 117d
Cleared Sep 13, 2010
RXPEAKFLOW
K101380
Noble Marketing
Anesthesiology · 119d
Cleared Apr 09, 2010
PEAK EXPIRATORY FLOW METER, KN-9710
K092335
K-Jump Health Co., Ltd.
Anesthesiology · 248d
Cleared Aug 21, 2009
CLEAN PEAK FLOW METER
K091412
Viasys Healthcare GmbH
Anesthesiology · 100d
Cleared Mar 10, 2009
DYNAMIPEAK PEAK FLOW METER
K082899
Dynamitech Medical, Inc.
Anesthesiology · 161d
Cleared Jan 31, 2006
MINI-WRIGHT DIGITAL, MODEL 3120001
K053156
Clement Clarke Intl., Ltd.
Anesthesiology · 78d
Cleared May 04, 2005
PMP4 SPIROPRO
K050853
Card Guard Scientific Survival , Ltd.
Anesthesiology · 30d
Cleared Jun 10, 2004
MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE)
K040723
Microlife Intellectual Property GmbH
Anesthesiology · 80d

About Product Code BZH - Regulatory Context

510(k) Submission Activity

81 total 510(k) submissions under product code BZH since 1977, with 81 receiving FDA clearance (average review time: 205 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - BZH Product Code

Recent submissions under BZH have taken an average of 307 days to reach a decision - up from 200 days historically. Manufacturers should account for longer review timelines in current project planning.

BZH devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →