Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1840](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1840) → BZG — Spirometer, Diagnostic # BZG · Spirometer, Diagnostic _Anesthesiology · 21 CFR 868.1840 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG ## Overview - **Product Code:** BZG - **Device Name:** Spirometer, Diagnostic - **Regulation:** [21 CFR 868.1840](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1840) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **3rd-party reviewable:** yes ## Identification A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 228) Showing 20 most recent of 228 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251777](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K251777.md) | MESI mTABLET SPIRO | Mesi D.O.O. | Mar 2, 2026 | SESE | | [K241843](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K241843.md) | TD-7301 Spirometer (TD-7301) | Gostar Co., Ltd. | Nov 20, 2024 | SESE | | [K231416](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K231416.md) | Air Next (NVD-02) | Nuvoair AB | Jan 18, 2024 | SESE | | [K230501](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K230501.md) | Spirobank Oxi | Mir Medical International Research USA | Dec 15, 2023 | SESE | | [K230178](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K230178.md) | EasyOne Sky Spirometer | Ndd Medizintechnik AG | Oct 19, 2023 | SESE | | [K222525](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K222525.md) | Alveoair Digital Spirometer | Roundworks Technologies Private Limited | Aug 28, 2023 | SESE | | [K222443](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K222443.md) | Air Smart Extra Spirometer | Feellife Health, Inc. | Aug 9, 2023 | SESE | | [K213754](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K213754.md) | SpiroHome Personal, SpiroHome Clinic | Inofab Saglik Teknolojileri A.S | Jun 12, 2023 | SESE | | [K213872](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K213872.md) | ComPAS2 | Morgan Scientific, Inc. | Jul 15, 2022 | SESE | | [K212938](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K212938.md) | Vitalograph Model 6000 Alpha | Vitalograph Ireland, Ltd. | Jan 26, 2022 | SESE | | [K201493](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K201493.md) | Spirometer | Mehow Innovative, Ltd. | Jun 10, 2021 | SESE | | [K202837](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K202837.md) | GoSpiro | Monitored Therapeutics, Inc. | Dec 4, 2020 | SESE | | [K201562](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K201562.md) | Spirotrac | Vitalograph Ireland, Ltd. | Oct 14, 2020 | SESE | | [K201002](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K201002.md) | Safey Pocket Spirometer | Safey Medical Devices Pvt, Ltd. | Jul 30, 2020 | SESE | | [K200550](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K200550.md) | Vitalograph Model 2120 In2itive eDiary | Vitalograph Ireland, Ltd. | Jul 27, 2020 | SESE | | [K183089](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K183089.md) | Air Next | Nuvoair AB | Jan 2, 2020 | SESE | | [K183479](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K183479.md) | Asthma Monitor AM3 | Eresearch Technology | Oct 3, 2019 | SESE | | [K191013](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K191013.md) | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option | Welch Allyn, Inc. | Sep 10, 2019 | SESE | | [K190568](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K190568.md) | ComPAS2 (Computerized Pulmonary Analysis System) | Morgan Scientific, Inc. | Jun 6, 2019 | SESE | | [K180011](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG/K180011.md) | Pulmonx Chartis Tablet Console | Pulmonx Corporation | Jul 13, 2018 | SESE | ## Top Applicants - Mir Medical Intl. Research Srl — 9 clearances - Sdi Diagnostics, Inc. — 8 clearances - Vitalograph (Ireland) , Ltd. — 6 clearances - Future Impex Corp. — 5 clearances - Medical Equipment Designs, Inc. — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZG) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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