Breathe+
FDA 510(k) K222018 · Peep Medical, LLC Dba Go2 Devices
510(k) numberK222018
Submission
- Device name
- Breathe+
- Applicant
- Peep Medical, LLC Dba Go2 Devices
Houston, TX, US - Received
- July 8, 2022
- Decision date
- June 2, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BWF – Spirometer, Therapeutic (Incentive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5690
- Specialty
- Anesthesiology
Other 510(k)s with product code BWF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241152 | InSeeBWF · Traditional | Tidal Medical Technologies, LLC | 08/21/2025SE |
| K233855 | AllPEPBWF · Traditional | Enchant Tek Co. , Ltd. | 02/02/2024SE |
| K221058 | LungTrainer (MD2 & MD3)BWF · Traditional | Lung Trainers, LLC | 07/05/2023SE |
| K220565 | Hudson RCI Triflo II Incentive Deep Breathing ExerciserBWF · Traditional | Medline Industries, Inc. | 10/25/2022SE |
| K203378 | PulsehalerBWF · Traditional | Respinova, Ltd. | 03/31/2021SE |
| K192000 | D R Burton OxyPAPBWF · Traditional | D R Burton Healthcare, LLC | 02/19/2020SE |
| K181660 | Acapella Choice Blue Vibratory PEP DeviceBWF · Traditional | Smiths Medical | 10/24/2019SE |
| K183108 | Combined Aerobika OPEP and VersaPAP deviceBWF · Traditional | Trudell Medical International | 08/16/2019SE |
| K182847 | Hudson RCI Voldyne Volumetric ExerciserBWF · Traditional | Teleflexmedical, Inc. | 07/01/2019SE |
| K173918 | VersaPAP Positive Airway Pressure (PAP) DeviceBWF · Traditional | Trudell Medical International | 08/17/2018SE |
Questions and answers
When was Breathe+ cleared by the FDA?
Breathe+ (K222018) received a 510(k) decision of Substantially Equivalent on June 2, 2023, 329 days after the submission was received.
What is the product code of K222018?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.