Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1890](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1890) → BTY — Calculator, Predicted Values, Pulmonary Function # BTY · Calculator, Predicted Values, Pulmonary Function _Anesthesiology · 21 CFR 868.1890 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY ## Overview - **Product Code:** BTY - **Device Name:** Calculator, Predicted Values, Pulmonary Function - **Regulation:** [21 CFR 868.1890](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1890) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **3rd-party reviewable:** yes ## Identification A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 63) Showing 20 most recent of 63 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K242809](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K242809.md) | Ascent Cardiorespiratory Diagnostic Software | Medical Graphics Corporation | Oct 17, 2024 | SESE | | [K223629](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K223629.md) | SpiroSphere, SpiroSphereECG, CardioSphere | Eresearchtechnology GmbH | May 28, 2024 | SESE | | [K231561](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K231561.md) | Pulmonary Function Tester, Model: A9 | Guangzhou Homesun Medical Technology Co., Ltd. | Feb 21, 2024 | SESE | | [K222982](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K222982.md) | Virtus Metabolic Monitor | Virtus Technology Aps | Jun 23, 2023 | SESE | | [K221030](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K221030.md) | Model 9100 PFT/DICO | Vitalograph Ireland, Ltd. | Jul 15, 2022 | SESE | | [K202754](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K202754.md) | MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU | Eresearchtechnology GmbH | Jan 28, 2021 | SESE | | [K190800](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K190800.md) | Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors | Cosmed Srl | Feb 6, 2020 | SESE | | [K181912](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K181912.md) | Ascent Cardiorespiratory Diagnostic Software | Medical Graphics Corporation | Apr 12, 2019 | SESE | | [K173937](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K173937.md) | SpiroSphere | Eresearchtechnology GmbH | Feb 15, 2019 | SESE | | [K161534](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K161534.md) | EasyOne Pro Respiratory Analysis System | Ndd Medizintechnik AG | Feb 22, 2017 | SESE | | [K150888](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K150888.md) | Shape-HF Cardiopulmonary Testing System | Shape Medical Systems, Inc. | Jan 21, 2016 | SESE | | [K122699](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K122699.md) | SENTRYSUITE PRODUCT LINE | Carefusion Germany 234 GmbH | Nov 19, 2012 | SESE | | [K120635](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K120635.md) | EASYONE PRO RESPIRATORY TESTING DEVICE | Ndd Medizitechnik AG | Sep 27, 2012 | SESE | | [K113813](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K113813.md) | SENTRYSUITE PRODUCT LINE | Carefusion Germany 234 GmbH | May 10, 2012 | SESE | | [K111053](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K111053.md) | SENTRYSUITE PRODUCT LINE | Carefusion Germany 234 GmbH | Aug 12, 2011 | SESE | | [K091428](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K091428.md) | EASYONE PRO RESPIRATORY ANALYSIS SYSTEM | Ndd Medizitechnik AG | Jan 27, 2010 | SESE | | [K090722](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K090722.md) | SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM | Shape Medical Systems, Inc. | Mar 31, 2009 | SESE | | [K082539](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K082539.md) | MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT | Cardinal Health Germany 234 GmbH | Dec 2, 2008 | SESE | | [K080510](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K080510.md) | VIP PULMONARY FUNCTION SYSTEM | Viasys Healthcare GmbH | Aug 20, 2008 | SESE | | [K080734](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K080734.md) | FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT | Viasys Healthcare GmbH | Jun 26, 2008 | SESE | ## Top Applicants - Viasys Healthcare GmbH — 5 clearances - Medical Associated Services, Inc. — 3 clearances - Eresearchtechnology GmbH — 3 clearances - Cosmed Srl — 3 clearances - Carefusion Germany 234 GmbH — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY) **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