Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1860](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1860) → BZH — Meter, Peak Flow, Spirometry # BZH · Meter, Peak Flow, Spirometry _Anesthesiology · 21 CFR 868.1860 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH ## Overview - **Product Code:** BZH - **Device Name:** Meter, Peak Flow, Spirometry - **Regulation:** [21 CFR 868.1860](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1860) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **3rd-party reviewable:** yes ## Identification A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 79) Showing 20 most recent of 79 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K241338](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K241338.md) | Peak Flow Meter | Chongqing Moffy Innovation Technology Co., Ltd. | Dec 31, 2024 | SESE | | [K232588](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K232588.md) | Aluna 2 | Knox Medical Diagnostics | Nov 25, 2024 | SESE | | [K230423](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K230423.md) | Electronic Peak Flow Meter | Taian Dalu Medical Instrument Co., Ltd. | Feb 23, 2024 | SESE | | [K222810](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K222810.md) | TD-7301 Peak Flow meter | Gostar Co., Ltd. | Dec 19, 2023 | SESE | | [K203196](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K203196.md) | Peak flow meter | Shanghai Sonmol Medical Equipment Co., Ltd. | May 26, 2021 | SESE | | [K200832](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K200832.md) | Safey Peak Flow Meter | Safey Medical Devices Pvt, Ltd. | Jul 30, 2020 | SESE | | [K193311](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K193311.md) | Aluna | Knox Medical Diagnostics, Inc. | Mar 25, 2020 | SESE | | [K191239](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K191239.md) | Smart Peak Flow Meter | Guangzhou Homesun Medical Technology Co., Ltd. | Dec 6, 2019 | SESE | | [K180487](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K180487.md) | Peak.me | Breathe Me, Ltd. | Oct 26, 2018 | SESE | | [K181666](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K181666.md) | Smart One | Mir Medical International Research | Aug 1, 2018 | SESE | | [K172804](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K172804.md) | Besmed Peak Flow Meter | Besmed Health Business Corp | Jan 11, 2018 | SESE | | [K170281](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K170281.md) | MSA100BT Peak Flow Meter | Beijing M&B Electronic Instruments Co., Ltd. | Oct 6, 2017 | SESE | | [K152276](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K152276.md) | Wing Smart FEVI and Peak Flow Meter | Sparo, Inc. | Jun 3, 2016 | SESE | | [K133975](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K133975.md) | MSA100 PEAK FLOW METER | Beijing M&B Electronic Instruments Co., Ltd. | Oct 3, 2014 | SESE | | [K123945](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K123945.md) | STRIVE DUAL ZONE PEAK FLOW METER | Monaghan Medical Corp. | Apr 17, 2013 | SESE | | [K101380](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K101380.md) | RXPEAKFLOW | Noble Marketing | Sep 13, 2010 | SESE | | [K092335](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K092335.md) | PEAK EXPIRATORY FLOW METER, KN-9710 | K-Jump Health Co., Ltd. | Apr 9, 2010 | SESE | | [K091412](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K091412.md) | CLEAN PEAK FLOW METER | Viasys Healthcare GmbH | Aug 21, 2009 | SESE | | [K082899](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K082899.md) | DYNAMIPEAK PEAK FLOW METER | Dynamitech Medical, Inc. | Mar 10, 2009 | SESE | | [K053156](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH/K053156.md) | MINI-WRIGHT DIGITAL, MODEL 3120001 | Clement Clarke Intl., Ltd. | Jan 31, 2006 | SESE | ## Top Applicants - Monaghan Medical Corp. — 10 clearances - Clement Clarke Intl., Ltd. — 4 clearances - Enact Health Management Systems — 3 clearances - Health Products, Inc. — 3 clearances - Healthscan Products, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZH) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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