Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1880](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1880) → BZC — Calculator, Pulmonary Function Data # BZC · Calculator, Pulmonary Function Data _Anesthesiology · 21 CFR 868.1880 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC ## Overview - **Product Code:** BZC - **Device Name:** Calculator, Pulmonary Function Data - **Regulation:** [21 CFR 868.1880](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1880) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **3rd-party reviewable:** yes ## Identification A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 90) Showing 20 most recent of 90 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K240293](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K240293.md) | STS | Techbopulm, Ltd. | Sep 17, 2024 | SESE | | [K183567](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K183567.md) | Vyntus/SentrySuite Product Line | Vyaire Medical | Aug 23, 2019 | SESE | | [K190853](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K190853.md) | Vyntus BODY | Vyaire Medical, Inc. | Aug 16, 2019 | SESE | | [K181524](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K181524.md) | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART | Vyaire Medical, Inc. | Nov 30, 2018 | SESE | | [K162515](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K162515.md) | COSMED K5 Wearable Metabolic Technology | Cosmed Srl | Jun 20, 2017 | SESE | | [K161295](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K161295.md) | MiniBox + | Pulmone Advanced Medical Devices, Ltd. | Oct 21, 2016 | SESE | | [K150810](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K150810.md) | Vyntus / SentrySuite Product Line | Carefusion Germany 234 GmbH | Aug 14, 2015 | SESE | | [K133925](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K133925.md) | VYNTUS/ SENTRYSUITE PRODUCT LINE | Carefusion Germany 234 GmbH | Aug 22, 2014 | SESE | | [K133051](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K133051.md) | PULMONE MINIBOX PFT TM | Pulmone Advanced Medical Devices, Ltd. | May 2, 2014 | SESE | | [K102047](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K102047.md) | LCI OPTION FOR INNOCOR | Innovision A/S | Nov 1, 2011 | SESE | | [K072323](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K072323.md) | MASTERSCREEN & OXYCON CPX | Viasys Healthcare GmbH | Oct 10, 2007 | SESE | | [K052328](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K052328.md) | ZAN LUNG-FUNCTION LAB | Zan Messgerate GmbH | Dec 22, 2005 | SESE | | [K040698](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K040698.md) | MASTERSCREEN CPX AND OXYCON CPX | Viasys Healthcare GmbH | Apr 7, 2004 | SESE | | [K023120](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K023120.md) | OXYCON MOBILE | Erich Jaeger GmbH | Nov 12, 2003 | SESE | | [K011344](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K011344.md) | INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 | Collins Medical, Inc. | May 17, 2002 | SESE | | [K001631](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K001631.md) | CORTEX METAMAX | Cortex Biophysik GmbH | Feb 22, 2001 | SESE | | [K001174](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K001174.md) | COSMED QUARK | Cosmed Srl | Jan 11, 2001 | SESE | | [K001502](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K001502.md) | AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO | Erich Jaeger GmbH | Jul 12, 2000 | SESE | | [K992214](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K992214.md) | OXYCON PRO | Erich Jaeger B.V. | Feb 22, 2000 | SESE | | [K982499](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K982499.md) | COSMO PLUS WITH NICO, MODEL 8200 | Novametrix Medical Systems, Inc. | Oct 16, 1998 | SESE | ## Top Applicants - Erich Jaeger, Inc. — 5 clearances - Novametrix Medical Systems, Inc. — 4 clearances - Warren E. Collins, Inc. — 4 clearances - Cardio Pulmonary Instruments — 3 clearances - Cosmed Srl — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC) **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. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com