BWF — Spirometer, Therapeutic (Incentive) Class II
FDA product code BWF covers "Spirometer, Therapeutic (Incentive)", a Class II medical device regulated under 21 CFR 868.5690. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BWF
- Device Class
- Class II
- Regulation Number
- 868.5690
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241152 | tidal medical technologies | InSee | August 21, 2025 |
| K233855 | enchant tek co. | AllPEP | February 2, 2024 |
| K221058 | lung trainers | LungTrainer (MD2 & MD3) | July 5, 2023 |
| K222018 | peep medical, llc dba go2 devices | Breathe+ | June 2, 2023 |
| K220565 | medline industries | Hudson RCI Triflo II Incentive Deep Breathing Exerciser | October 25, 2022 |
| K203378 | respinova | Pulsehaler | March 31, 2021 |
| K192000 | d r burton healthcare | D R Burton OxyPAP | February 19, 2020 |
| K181660 | smiths medical | Acapella Choice Blue Vibratory PEP Device | October 24, 2019 |
| K183108 | trudell medical international | Combined Aerobika OPEP and VersaPAP device | August 16, 2019 |
| K182847 | teleflexmedical | Hudson RCI Voldyne Volumetric Exerciser | July 1, 2019 |
| K173918 | trudell medical international | VersaPAP Positive Airway Pressure (PAP) Device | August 17, 2018 |
| K172388 | advanced circulatory system, a wholly owned subsidiary of | VPOD ITPR | December 22, 2017 |
| K160837 | medinet | MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM | February 23, 2017 |
| K163091 | medica holdings | VibraPEP | February 21, 2017 |
| K160636 | d r burton healthcare | iPEP System and vPEP | August 3, 2016 |
| K150044 | pari respiratory equipment | O-PEP | May 27, 2016 |
| K153441 | medica holdings | VibraPEP | March 25, 2016 |
| K150173 | trudell medical international | Aerobika OPEP Devive with Manometer | October 15, 2015 |
| K140772 | actegy | AEROSURE MEDIC | December 19, 2014 |
| K141355 | besmed health business corporation | VOLUMETRIC INCENTIVE SPIROMETER | September 3, 2014 |