Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1850](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1850) → BZK — Spirometer, Monitoring (W/Wo Alarm) # BZK · Spirometer, Monitoring (W/Wo Alarm) _Anesthesiology · 21 CFR 868.1850 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK ## Overview - **Product Code:** BZK - **Device Name:** Spirometer, Monitoring (W/Wo Alarm) - **Regulation:** [21 CFR 868.1850](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1850) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **3rd-party reviewable:** yes ## Identification A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 61) Showing 20 most recent of 61 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K192584](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K192584.md) | BEACON Caresystem Model 00002144 | Mermaid Care A/S | Dec 18, 2019 | SESE | | [K192595](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K192595.md) | ExSpiron 2Xi | Respiratory Motion | Dec 17, 2019 | SESE | | [K180788](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K180788.md) | Gas Module 3 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Oct 24, 2018 | SESE | | [K173181](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K173181.md) | ExSpiron 1Xi | Respiratory Motion, Inc. | Mar 16, 2018 | SESE | | [K162131](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K162131.md) | ExSpiron 1Xi | Respiratory Motion, Inc. | May 9, 2017 | SESE | | [K130170](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K130170.md) | EXSPIRON 1XI | Respiratory Motion, Inc. | May 29, 2013 | SESE | | [K120087](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K120087.md) | EXSPIRON | Respiratory Motion, Inc. | Sep 26, 2012 | SESE | | [K103578](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K103578.md) | PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST | Respironics Novametrix, LLC | Jun 2, 2011 | SESE | | [K091853](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K091853.md) | WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014 | Nspire Health, Inc. | Sep 21, 2009 | SESE | | [K092217](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K092217.md) | MERCURY VCO2 | Respironics Novametrix, Inc. | Aug 21, 2009 | SESE | | [K091459](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K091459.md) | PHILIPS NM3 MONITOR, MODEL 7900 | Respironics Novametrix, LLC | Jul 28, 2009 | SESE | | [K080652](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K080652.md) | MERCURY VCO2 MODULE WITH CAPNOSTAT 5 | Respironics Novametrix, LLC | Jun 20, 2008 | SESE | | [K062754](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K062754.md) | GAS MODULE SE, MODEL 0998-00-0481-02 | Datascope Corp. | Nov 2, 2006 | SESE | | [K051279](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K051279.md) | CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 | Caldyne, Inc. | Sep 7, 2005 | SESE | | [K983274](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K983274.md) | STARTRACK INFANT GRAPHICS MONITOR | Nellcor Puritan Bennett, Inc. | Dec 9, 1998 | SESE | | [K972086](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K972086.md) | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311 | Alexander Mfg. Co. | Aug 12, 1997 | SESE | | [K932098](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K932098.md) | CAPNOMAC ULTIMA ANESTHESIA MONITOR | Datex Division Instrumentarium Corp. | Nov 29, 1993 | SESE | | [K931542](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K931542.md) | NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR | Newport Medical Instruments, Inc. | Oct 25, 1993 | SESE | | [K921717](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K921717.md) | BICORE SMARTVALVE OCCLUSION VALVE | Bicore Monitoring Systems | Nov 6, 1992 | SESE | | [K903674](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK/K903674.md) | MODEL 295 ELECTRONIC RESPIROMETER | National Medical Sales, Inc. | Jan 4, 1991 | SESE | ## Top Applicants - Respitrace Corp. — 6 clearances - Respiratory Motion, Inc. — 4 clearances - Ohmeda Medical — 4 clearances - Bear Medical Systems, Inc. — 4 clearances - Respironics Novametrix, LLC — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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