BWF — Spirometer, Therapeutic (Incentive) Class II
FDA Device Classification
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 |