O-Pep
FDA 510(k) K150044 · Pari Respiratory Equipment, Inc.
510(k) numberK150044
Submission
- Device name
- O-Pep
- Applicant
- Pari Respiratory Equipment, Inc.
Midlothian, VA, US - Received
- January 12, 2015
- Decision date
- May 27, 2016
- 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 |
| K222018 | Breathe+BWF · Traditional | Peep Medical, LLC Dba Go2 Devices | 06/02/2023SE |
| 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 |
More from Teleflexmedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251572 | eRapid with eTrack SystemCAF · Traditional | 12/19/2025SE |
| K223840 | eRapid Nebulizer SystemCAF · Traditional | 08/11/2023SE |
| K191270 | Proneb MaxCAF · Traditional | 01/23/2020SE |
| K162785 | Velox Nebulizer SystemCAF · Traditional | 04/14/2017SE |
| K112859 | Erapid Nebulizer SystemCAF · Traditional | 05/30/2012SE |
| K092560 | Pari SinusCAF · Traditional | 05/06/2010SE |
| K100380 | Altera Nebulizer System, Model 678G1002CAF · Traditional | 02/22/2010SE |
| K092918 | Pari ViosCAF · Traditional | 02/04/2010SE |
| K090829 | Pari Pep SBWF · Traditional | 07/21/2009SE |
Questions and answers
When was O-Pep cleared by the FDA?
O-Pep (K150044) received a 510(k) decision of Substantially Equivalent on May 27, 2016, 501 days after the submission was received.
What is the product code of K150044?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.