Product Code: BZH FDA class 2 21 CFR 868.1860

Meter, Peak Flow, Spirometry

Anesthesiology

The Meter, Peak Flow, Spirometry is a portable or clinical device used to measure peak expiratory flow rate, providing a simple and rapid assessment of large airway obstruction useful in managing asthma and other obstructive lung conditions. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BZH, regulated under 21 CFR 868.1860 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

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FEI Numbers

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Basic Information

Product Code: BZH
Device Class: FDA class 2
Regulation Number: 868.1860
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 80 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252802	Peak Flow Meter (PF-10(BR-PEF231))	May 29, 2026	Substantially Equivalent	Shenzhen Bi-Rich Medical Devices Co., Ltd.
K241338	Peak Flow Meter	Dec 31, 2024	Substantially Equivalent	Chongqing Moffy Innovation Technology Co., Ltd.
K232588	Aluna 2	Nov 25, 2024	Substantially Equivalent	Knox Medical Diagnostics
K230423	Electronic Peak Flow Meter	Feb 23, 2024	Substantially Equivalent	Taian Dalu Medical Instrument Co., Ltd.
K222810	TD-7301 Peak Flow meter	Dec 19, 2023	Substantially Equivalent	Gostar Co., Ltd.
K203196	Peak flow meter	May 26, 2021	Substantially Equivalent	Shanghai Sonmol Medical Equipment Co., Ltd.
K200832	Safey Peak Flow Meter	Jul 30, 2020	Substantially Equivalent	Safey Medical Devices Pvt, Ltd.
K193311	Aluna	Mar 25, 2020	Substantially Equivalent	Knox Medical Diagnostics, Inc.
K191239	Smart Peak Flow Meter	Dec 06, 2019	Substantially Equivalent	Guangzhou Homesun Medical Technology Co., Ltd.
K180487	Peak.me	Oct 26, 2018	Substantially Equivalent	Breathe Me, Ltd.
K181666	Smart One	Aug 01, 2018	Substantially Equivalent	Mir Medical International Research
K172804	Besmed Peak Flow Meter	Jan 11, 2018	Substantially Equivalent	Besmed Health Business Corp
K170281	MSA100BT Peak Flow Meter	Oct 06, 2017	Substantially Equivalent	Beijing M&B Electronic Instruments Co., Ltd.
K152276	Wing Smart FEVI and Peak Flow Meter	Jun 03, 2016	Substantially Equivalent	Sparo, Inc.
K133975	MSA100 PEAK FLOW METER	Oct 03, 2014	Substantially Equivalent	Beijing M&B Electronic Instruments Co., Ltd.
K123945	STRIVE DUAL ZONE PEAK FLOW METER	Apr 17, 2013	Substantially Equivalent	Monaghan Medical Corp.
K101380	RXPEAKFLOW	Sep 13, 2010	Substantially Equivalent	Noble Marketing
K092335	PEAK EXPIRATORY FLOW METER, KN-9710	Apr 09, 2010	Substantially Equivalent	K-Jump Health Co., Ltd.
K091412	CLEAN PEAK FLOW METER	Aug 21, 2009	Substantially Equivalent	Viasys Healthcare GmbH
K082899	DYNAMIPEAK PEAK FLOW METER	Mar 10, 2009	Substantially Equivalent	Dynamitech Medical, Inc.
K053156	MINI-WRIGHT DIGITAL, MODEL 3120001	Jan 31, 2006	Substantially Equivalent	Clement Clarke Intl., Ltd.
K050853	PMP4 SPIROPRO	May 04, 2005	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K040723	MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE)	Jun 10, 2004	Substantially Equivalent	Microlife Intellectual Property GmbH
K031024	MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100	Nov 14, 2003	Substantially Equivalent	Microlife Corp.
K030586	MICROPEAK	Aug 27, 2003	Substantially Equivalent	Micro Direct, Inc.
K031514	MODIFICATION TO TRUPEAK PEAK FLOW METER	May 23, 2003	Substantially Equivalent	Monaghan Medical Corp.
K022124	GALEMED PEAK FLOW METER, MODELS 3751/3752	Apr 03, 2003	Substantially Equivalent	Galemed Corp.
K023097	TRUEZONE PEAK FLOW METER	Mar 07, 2003	Substantially Equivalent	Monaghan Medical Corp.
K013489	KP + LFM	Nov 29, 2001	Substantially Equivalent	Pds Healthcare Products, Inc.
K010009	KOKO PEAK KP; KOKO PEAK KP+	Jun 01, 2001	Substantially Equivalent	Pds Healthcare Products, Inc.
K980951	ONEFLOW	Feb 25, 2000	Substantially Equivalent	Sti Medical
K991412	VITALOGRAPH MICRO	Feb 04, 2000	Substantially Equivalent	Vitalograph, Inc.
K992618	RESPALERT	Oct 29, 1999	Substantially Equivalent	Harwill Medical (Pty) , Ltd.
K991212	MODIFICATION TO TRUZONE PEAK FLOW METER	Jul 01, 1999	Substantially Equivalent	Monaghan Medical Corp.
K982334	AIRZONE PEAK FLOWMETER	Jan 14, 1999	Substantially Equivalent	Clement Clarke Intl., Ltd.
K982995	ACCUTRAX, MODEL EPF840	Dec 04, 1998	Substantially Equivalent	Korr Medical Technologies, Inc.
K982676	AIRWATCH II ZONE	Oct 29, 1998	Substantially Equivalent	Enact Health Management Systems
K982675	AIRWATCH II ZONELESS	Oct 29, 1998	Substantially Equivalent	Enact Health Management Systems
K980550	WHISTLE WATCH	Aug 27, 1998	Substantially Equivalent	Harwill Medical (Pty) , Ltd.
K980960	IN-CHECK INSPIRATORY FLOWMETER	Jun 10, 1998	Substantially Equivalent	Clement Clarke Intl., Ltd.
K980443	PEAK FLOW METER MINIMAX	Apr 30, 1998	Substantially Equivalent	The D&T, Inc.
K970507	PEAK FLOW METER	Jun 13, 1997	Substantially Equivalent	Intl. Medical, Inc.
K961779	MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER	Jun 13, 1997	Substantially Equivalent	Avion Medical Products, Inc.
K964130	AEROGEAR ASTHMA ACTION KIT	Jan 10, 1997	Substantially Equivalent	Monaghan Medical Corp.
K962074	VM PLUS PEAK FLOWMETER	Jan 02, 1997	Substantially Equivalent	Clement Clarke Intl., Ltd.
K963089	TRUZONE PEAK FLOW METER	Nov 06, 1996	Substantially Equivalent	Monaghan Medical Corp.
K963095	TRUPEAK PEAK FLOW METER	Nov 04, 1996	Substantially Equivalent	Monaghan Medical Corp.
K962924	PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM	Oct 25, 1996	Substantially Equivalent	Healthscan Products, Inc.
K962929	PERSONAL BEST II	Oct 24, 1996	Substantially Equivalent	Healthscan Products, Inc.
K953411	BREATH-TAKER BREATH-ALERT	Jun 13, 1996	Substantially Equivalent	Roxon - Universal Medical , Ltd.
K952909	AUTOZONE	Mar 29, 1996	Substantially Equivalent	Health Scan, Inc.
K952713	MINI WRIGHT LR AFS	Mar 29, 1996	Substantially Equivalent	Clement Clarke, Inc.
K955234	TRUPEAK PEAK FLOW METER	Mar 18, 1996	Substantially Equivalent	Monaghan Medical Corp.
K955262	TRUZONE PEAK FLOW METER	Mar 07, 1996	Substantially Equivalent	Monaghan Medical Corp.
K954277	ASTECH PEAK FLOW METER	Feb 21, 1996	Substantially Equivalent	Center Laboratories, Inc.
K943678	ELECTRONIC FLOW METER	Dec 14, 1995	Substantially Equivalent	Vitalograph, Inc.
K953458	RAINBOW STEP UP SYSTEMS INC. ASTHMA HOME CARE PLAN	Nov 17, 1995	Unknown	Raiinbow Step UP Systems, Inc.
K934795	CARD GUARD	Apr 14, 1995	Substantially Equivalent	Card Guard Scientific Survival , Ltd.
K936110	ASPIRE	Mar 23, 1995	Substantially Equivalent	Dura Pharmaceuticals, Inc.
K941226	AIRWATCH MONITOR	Nov 16, 1994	Substantially Equivalent	Enact Health Management Systems
K940836	PEAKLOG AND DISPLAY SOFTWARE	Nov 01, 1994	Substantially Equivalent	Tamarac Systems Corp.
K940835	PEAKLOG AND DISPLAY SOFTWARE	Nov 01, 1994	Substantially Equivalent	Medtrac Technologies Corp.
K924322	FLOW=MED	Apr 26, 1994	Substantially Equivalent	International Electronic Technology Corp.
K934502	FLOW SPIROMETER	Apr 04, 1994	Substantially Equivalent	Healthdyne, Inc.
K933889	PERSONAL BEST LOW RANGE	Sep 09, 1993	Substantially Equivalent	Healthscan Products, Inc.
K926307	PEAK FLOW METER	Jul 22, 1993	Substantially Equivalent	Monaghan Medical Corp.
K924343	WRIGHT POCKET PEAK FLOW METER	Jun 16, 1993	Substantially Equivalent	Ferraris Medical, Inc.
K914126	VMX MINI-LOG FLOWMETER	Mar 05, 1993	Substantially Equivalent	Clement Clarke, Inc.
K920390	THE PEAK	Sep 11, 1992	Substantially Equivalent	Multispiro, Inc.
K915060	ASTECH HOME PEAK FLOW METER	Sep 11, 1992	Substantially Equivalent	Biotrine Corp.
K912866	PEAK EXPIRATORY FLOW METER	Aug 13, 1992	Substantially Equivalent	Health Products, Inc.
K915059	PEAK FLOW MONITOR	Jul 27, 1992	Substantially Equivalent	Spirometrics, Inc.
K902292	MODIFIED ASSESS(R) PEAK FLOW METER	Aug 10, 1990	Substantially Equivalent	Health Products, Inc.
K896953	MODIFIED ASSESS(R) PEAK FLOW METER	Jan 30, 1990	Substantially Equivalent	Health Products, Inc.
K853922	PLOTTER FOR AS-500	Nov 14, 1985	Substantially Equivalent	Riko Medical & Scientific Instrument Corp.
K851265	PEAK FLOWMETERS FOR SPIROMETRY	Oct 29, 1985	Substantially Equivalent	Solcoor, Inc.
K813414	PEAK FLOW MONITOR	Dec 31, 1981	Substantially Equivalent	Biotrine Corp.
K781922	PULMONARY MONITOR	Feb 13, 1979	Substantially Equivalent	Vitalograph , Ltd.
K781224	METER, FLOW, PEAK	Oct 15, 1978	Substantially Equivalent	Projects IN Health
K770580	PEAK FLOW METER	Aug 04, 1977	Substantially Equivalent	Projects IN Health