Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5690](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5690) → BWF — Spirometer, Therapeutic (Incentive) # BWF · Spirometer, Therapeutic (Incentive) _Anesthesiology · 21 CFR 868.5690 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF ## Overview - **Product Code:** BWF - **Device Name:** Spirometer, Therapeutic (Incentive) - **Regulation:** [21 CFR 868.5690](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5690) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **3rd-party reviewable:** yes ## Identification An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 108) Showing 20 most recent of 108 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K241152](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K241152.md) | InSee | Tidal Medical Technologies, LLC | Aug 21, 2025 | SESE | | [K233855](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K233855.md) | AllPEP | Enchant Tek Co. , Ltd. | Feb 2, 2024 | SESE | | [K221058](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K221058.md) | LungTrainer (MD2 & MD3) | Lung Trainers, LLC | Jul 5, 2023 | SESE | | [K222018](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K222018.md) | Breathe+ | Peep Medical, LLC Dba Go2 Devices | Jun 2, 2023 | SESE | | [K220565](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K220565.md) | Hudson RCI Triflo II Incentive Deep Breathing Exerciser | Medline Industries, Inc. | Oct 25, 2022 | SESE | | [K203378](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K203378.md) | Pulsehaler | Respinova, Ltd. | Mar 31, 2021 | SESE | | [K192000](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K192000.md) | D R Burton OxyPAP | D R Burton Healthcare, LLC | Feb 19, 2020 | SESE | | [K181660](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K181660.md) | Acapella Choice Blue Vibratory PEP Device | Smiths Medical | Oct 24, 2019 | SESE | | [K183108](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K183108.md) | Combined Aerobika OPEP and VersaPAP device | Trudell Medical International | Aug 16, 2019 | SESE | | [K182847](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K182847.md) | Hudson RCI Voldyne Volumetric Exerciser | Teleflexmedical, Inc. | Jul 1, 2019 | SESE | | [K173918](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K173918.md) | VersaPAP Positive Airway Pressure (PAP) Device | Trudell Medical International | Aug 17, 2018 | SESE | | [K172388](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K172388.md) | VPOD ITPR | Advanced Circulatory System, A Wholly Owned Subsidiary OF | Dec 22, 2017 | SESE | | [K160837](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K160837.md) | MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM | Medinet Srl | Feb 23, 2017 | SESE | | [K163091](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K163091.md) | VibraPEP | Medica Holdings, LLC | Feb 21, 2017 | SESE | | [K160636](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K160636.md) | iPEP System and vPEP | D R Burton Healthcare, LLC | Aug 3, 2016 | SESE | | [K150044](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K150044.md) | O-PEP | Pari Respiratory Equipment, Inc. | May 27, 2016 | SESE | | [K153441](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K153441.md) | VibraPEP | Medica Holdings, LLC | Mar 25, 2016 | SESE | | [K150173](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K150173.md) | Aerobika OPEP Devive with Manometer | Trudell Medical International | Oct 15, 2015 | SESE | | [K140772](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K140772.md) | AEROSURE MEDIC | Actegy , Ltd. | Dec 19, 2014 | SESE | | [K141355](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K141355.md) | VOLUMETRIC INCENTIVE SPIROMETER | Besmed Health Business Corporation | Sep 3, 2014 | SESE | ## Top Applicants - Dhd Healthcare Corp. — 5 clearances - Dhd Medical Products Div. Diemolding Corp. — 4 clearances - Health Products, Inc. — 4 clearances - Advanced Circulatory Systems, Inc. — 3 clearances - Chesebrough-Pond'S U.S.A. Co. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF) **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