Medex M20754
Medex M20754 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K820355 on 4 Mar 1982 and listed in FDA GUDID since 11 Oct 2016 (UDI-DI 10351688510686), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10351688510686 | Date11 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK820355 | Date4 Mar 1982 | StatusActive |
Official records
- AccessGUDID record 10351688510686
- FDA 510(k) database K820355
Across registries
- FDA 510(k) K820355 decided 4 Mar 1982 Active
- FDA GUDID UDI-DI 10351688510686 listed 11 Oct 2016 Listed
Recalls
-
- Ongoing Z-0739-2024
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Timeline
- Cleared FDA 510(k) K820355
- Listed FDA GUDID 10351688510686
- Recall initiated FDA recalls Z-0739-2024
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Medex
- Generic name
- Pressure transducer dome, single-use
- Model / reference
- M20754
- Primary DI / UDI-DI
- 10351688510686
- 510(k) Number
- FDA product code
- DRS
- GMDN term
- Pressure transducer dome, single-use
- Device class
- Class II
- Regulation number
- 870.2850
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Ethylene Oxide