BWF · Spirometer, Therapeutic (Incentive)
Anesthesiology · 21 CFR 868.5690 · Class 2
Overview
| Product Code | BWF |
|---|---|
| Device Name | Spirometer, Therapeutic (Incentive) |
| Regulation | 21 CFR 868.5690 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 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 | InSee | Tidal Medical Technologies, LLC | Aug 21, 2025 | SESE |
| K233855 | AllPEP | Enchant Tek Co. , Ltd. | Feb 2, 2024 | SESE |
| K221058 | LungTrainer (MD2 & MD3) | Lung Trainers, LLC | Jul 5, 2023 | SESE |
| K222018 | Breathe+ | Peep Medical, LLC Dba Go2 Devices | Jun 2, 2023 | SESE |
| K220565 | Hudson RCI Triflo II Incentive Deep Breathing Exerciser | Medline Industries, Inc. | Oct 25, 2022 | SESE |
| K203378 | Pulsehaler | Respinova, Ltd. | Mar 31, 2021 | SESE |
| K192000 | D R Burton OxyPAP | D R Burton Healthcare, LLC | Feb 19, 2020 | SESE |
| K181660 | Acapella Choice Blue Vibratory PEP Device | Smiths Medical | Oct 24, 2019 | SESE |
| K183108 | Combined Aerobika OPEP and VersaPAP device | Trudell Medical International | Aug 16, 2019 | SESE |
| K182847 | Hudson RCI Voldyne Volumetric Exerciser | Teleflexmedical, Inc. | Jul 1, 2019 | SESE |
| K173918 | VersaPAP Positive Airway Pressure (PAP) Device | Trudell Medical International | Aug 17, 2018 | SESE |
| K172388 | VPOD ITPR | Advanced Circulatory System, A Wholly Owned Subsidiary OF | Dec 22, 2017 | SESE |
| K160837 | MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM | Medinet Srl | Feb 23, 2017 | SESE |
| K163091 | VibraPEP | Medica Holdings, LLC | Feb 21, 2017 | SESE |
| K160636 | iPEP System and vPEP | D R Burton Healthcare, LLC | Aug 3, 2016 | SESE |
| K150044 | O-PEP | Pari Respiratory Equipment, Inc. | May 27, 2016 | SESE |
| K153441 | VibraPEP | Medica Holdings, LLC | Mar 25, 2016 | SESE |
| K150173 | Aerobika OPEP Devive with Manometer | Trudell Medical International | Oct 15, 2015 | SESE |
| K140772 | AEROSURE MEDIC | Actegy , Ltd. | Dec 19, 2014 | SESE |
| K141355 | 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
