LiDCO Ltd Li11147
LiDCO Ltd Li11147 is a Class II device made by Lidco Limited, cleared under FDA 510(k) K163334 on 5 Jun 2017 and listed in FDA GUDID since 17 Nov 2017 (UDI-DI 05060110522583), active as of 22 Oct 2026. One FDA recall is 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 | Number05060110522583 | Date17 Nov 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163334 | Date5 Jun 2017 | StatusActive |
Official records
- AccessGUDID record 05060110522583
- FDA 510(k) database K163334
Across registries
- FDA 510(k) K163334 decided 5 Jun 2017 Active
- FDA GUDID UDI-DI 05060110522583 listed 17 Nov 2017 Listed
Recalls
-
- Terminated Z-0756-2021
The expiration date on labeling is incorrect.
Timeline
- Cleared FDA 510(k) K163334
- Listed FDA GUDID 05060110522583
- Recall initiated FDA recalls Z-0756-2021
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- LiDCO Ltd
- Generic name
- General-purpose multi-parameter bedside monitor
- Model / Ref / Catalog
- Li11147
- Primary DI / UDI-DI
- 05060110522583
- 510(k) Number
- FDA product code
- DXG
- GMDN term
- General-purpose multi-parameter bedside monitor
- Device class
- Class II
- Regulation number
- 870.1435
- GUDID distribution status
- In Commercial Distribution