LiDCO Ltd Li10797

by Lidco Limited

LiDCO Ltd Li10797 is a Class II device made by Lidco Limited, cleared under FDA 510(k) K122247 on 20 Mar 2013 and listed in FDA GUDID since 13 Sep 2016 (UDI-DI 05060110521579), 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	Number05060110521579 UDI-DI	Date13 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK122247	Date20 Mar 2013Decided	StatusActive

Official records

AccessGUDID record UDI-DI 05060110521579
FDA 510(k) database 510(k) number K122247

Across registries

2 registries list this device

FDA 510(k) K122247 decided 20 Mar 2013 Active
FDA GUDID UDI-DI 05060110521579 listed 13 Sep 2016 Listed

Timeline

2 dated events

20 Mar 2013 Cleared FDA 510(k) K122247
13 Sep 2016 Listed FDA GUDID 05060110521579

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Withdrawn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: Li10797

Primary DI / UDI-DI: 05060110521579
510(k) Number: K122247
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
Lot / batch number

Other properties (13, all answered No)