Portex 8500P
Portex 8500P is a pulmonary resuscitator (FDA Class II; FDA product code BTM, Ventilator, emergency, manual (resuscitator)) made by ICU Medical, Inc., cleared under FDA 510(k) K014115 on 27 Feb 2002 and listed in FDA GUDID since 29 Jul 2015 (UDI-DI 10351688431233), active as of 23 Oct 2026. 3 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10351688431233 | Date29 Jul 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK014115 | Date27 Feb 2002 | StatusActive |
Official records
- AccessGUDID record 10351688431233
- FDA 510(k) database K014115
Across registries
- FDA 510(k) K014115 decided 27 Feb 2002 Active
- FDA GUDID UDI-DI 10351688431233 listed 29 Jul 2015 Listed
Recalls
-
- Terminated Z-0808-03
- Terminated Z-0810-03
- Terminated Z-0809-03
Peep valve set at the highest level and could result in patient injury
Timeline
- Cleared FDA 510(k) K014115
- Recall initiated FDA recalls Z-0808-03
- Recall initiated FDA recalls Z-0810-03
- Recall initiated FDA recalls Z-0809-03
- Listed FDA GUDID 10351688431233
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Portex
- Generic name
- Pulmonary resuscitator, manual, single-use
- Model / reference
- 8500P
- Primary DI / UDI-DI
- 10351688431233
- 510(k) Number
- FDA product code
- BTM
- GMDN term
- Pulmonary resuscitator, manual, single-use
- Device class
- Class II
- Regulation number
- 868.5915
- GUDID distribution status
- In Commercial Distribution
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