PocketPEP with OxyJET 1
PocketPEP with OxyJET 1 (537) is a Class II device made by D R Burton Healthcare, LLC, cleared under FDA 510(k) K160636 on 3 Aug 2016 and listed in FDA GUDID since 10 Apr 2020 (UDI-DI 00851232007684), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00851232007684 | Date10 Apr 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160636 | Date3 Aug 2016 | StatusActive |
Official records
- AccessGUDID record 00851232007684
- FDA 510(k) database K160636
Across registries
- FDA 510(k) K160636 decided 3 Aug 2016 Active
- FDA GUDID UDI-DI 00851232007684 listed 10 Apr 2020 Listed
Timeline
- Cleared FDA 510(k) K160636
- Listed FDA GUDID 00851232007684
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PocketPEP with OxyJET
- Generic name
- Incentive spirometer
- Model / Ref / Catalog
- 1, 537
- Primary DI / UDI-DI
- 00851232007684
- 510(k) Number
- FDA product code
- BWF
- GMDN term
- Incentive spirometer
- Device class
- Class II
- Regulation number
- 868.5690
- GUDID distribution status
- In Commercial Distribution
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