Portex 292003
Portex 292003 is an artificial airway tube cuff pressure monitor (FDA Class II; FDA product code BSK, Cuff, tracheal tube, inflatable) made by ICU Medical, Inc., cleared under FDA 510(k) K833327 on 28 Nov 1983 and listed in FDA GUDID since 7 Aug 2015 (UDI-DI 10351688517166), active as of 23 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 | Number10351688517166 | Date7 Aug 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK833327 | Date28 Nov 1983 | StatusActive |
Official records
- AccessGUDID record 10351688517166
- FDA 510(k) database K833327
Across registries
- FDA 510(k) K833327 decided 28 Nov 1983 Active
- FDA GUDID UDI-DI 10351688517166 listed 7 Aug 2015 Listed
Timeline
- Cleared FDA 510(k) K833327
- Listed FDA GUDID 10351688517166
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Portex
- Generic name
- Artificial airway tube cuff pressure monitor
- Model / reference
- 292003
- Primary DI / UDI-DI
- 10351688517166
- 510(k) Number
- FDA product code
- BSK
- GMDN term
- Artificial airway tube cuff pressure monitor
- Device class
- Class II
- Regulation number
- 868.5750
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code BSK (Cuff, tracheal tube, inflatable).
- POSEY CUFFLATOR by Posey Co.
- BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR by Instrumentation Industries, Inc.
- CUFF BARO GUARD OR CBG ABBREVIATED by Nelson Engineering, Inc.
- IntelliCuff by Hamilton Medical AG
- CUFFALERT by SunMed
- RESPIRONICS PR VALVE by Respironics, Inc.
- CUFFCHECK by Dhd Medical Products Div. Diemolding Corp.
- Accucuff Cuff Pressure Indicator by Tianjin Medis Medical Device Co., Ltd.
- Puritan Bennett Cuff Pressure Manager by Covidien llc
- CuffTrek by Shanghai Longmann Tech Co., Ltd.