iPEP System and vPEP
510(k) K160636
iPEP System and vPEP is a Class II device made by D R Burton Healthcare, LLC, cleared under FDA 510(k) K160636 on 3 Aug 2016, 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 | FDA 510(k)SESE | NumberK160636 | Date3 Aug 2016 | StatusActive |
Official records
- FDA 510(k) database K160636
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BWF
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5690
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K160636
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| iPEP 1 | 520 / 1 | 00851232007530 | — | On the market |
| PocketPEP 1 | 530 / 1 | 00851232007578 | — | On the market |
| PocketPEP Advantage 1 | 535 / 1 | 00851232007554 | — | On the market |
| PocketPEP Advantage with OxyJET 1 | 538 / 1 | 00851232007721 | — | No longer on the market |
| PocketPEP OPEP DEVICE w/ T-PIECE ADAPTER & MOUTHPIECE 1 | 533 / 1 | 00851232007585 | — | On the market |
| PocketPEP with OxyJET 1 | 537 / 1 | 00851232007684 | — | On the market |
| vPEP 1 | 502 / 1 | 00851232007127 | — | On the market |
| vPEP OPEP DEVICE 1 | 510 / 1 | 00851232007011 | — | On the market |
| vPEP-HC 1 | 512 / 1 | 00851232007028 | — | On the market |
| vPEP-HC OPEP DEVICE WITH T-PIECE ADAPTER 1 | 512-T / 1 | 00851232007080 | — | On the market |
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