Pari Pep Therapy System
FDA 510(k) K972042 · Pari Holding Co.
510(k) numberK972042
Submission
- Device name
- Pari Pep Therapy System
- Applicant
- Pari Holding Co.
Midlothian, VA, US - Received
- June 2, 1997
- Decision date
- August 5, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BWF – Spirometer, Therapeutic (Incentive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5690
- Specialty
- Anesthesiology
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| 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 |
|---|---|---|
| K002862 | Proneb Ultra Model Number 85B0100BTI · Traditional | 03/13/2001SE |
| K983308 | RC Cornet, Model #44F50BWF · Traditional | 06/04/1999SE |
| K963924 | LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70CAF · Traditional | 12/10/1996SE |
| K962072 | Proneb Turbo Compressor Model 38V0200CAF · Traditional | 08/21/1996SE |
| K960675 | Walkhaler Portable Compressor Model 45F70CAF · Traditional | 05/17/1996SE |
| K935540 | Pari-Master ModificationCAF · Traditional | 03/17/1995SE |
| K944152 | Pari BabyCAF · Traditional | 11/18/1994SE |
Questions and answers
When was Pari Pep Therapy System cleared by the FDA?
Pari Pep Therapy System (K972042) received a 510(k) decision of Substantially Equivalent on August 5, 1997, 64 days after the submission was received.
What is the product code of K972042?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.