LiDCO Ltd CM 35-01

by Lidco Limited

LiDCO Ltd CM 35-01 is a Class II device made by Lidco Limited, cleared under FDA 510(k) K010049 on 14 Jun 2001 and listed in FDA GUDID since 7 Sep 2016 (UDI-DI 05060110520305), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number05060110520305 UDI-DI	Date7 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK010049	Date14 Jun 2001Decided	StatusActive

Official records

AccessGUDID record UDI-DI 05060110520305
FDA 510(k) database 510(k) number K010049

Across registries

2 registries list this device

FDA 510(k) K010049 decided 14 Jun 2001 Active
FDA GUDID UDI-DI 05060110520305 listed 7 Sep 2016 Listed

Timeline

2 dated events

14 Jun 2001 Cleared FDA 510(k) K010049
7 Sep 2016 Listed FDA GUDID 05060110520305

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: LiDCO Ltd
Generic name: General-purpose multi-parameter bedside monitor
Model / Ref / Catalog: CM 35-01

Primary DI / UDI-DI: 05060110520305
510(k) Number: K010049
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

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Properties

Prescription use
Serial number

Other properties (13, all answered No)