Data / Medical devices / United Kingdom / Lidco Ltd.

Lidco Ltd.: FDA-registered device maker in LONDON England, United Kingdom, 6 510(k) clearances

Name: Lidco Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Lidco Ltd. is registered with the FDA (registration 9617127) in LONDON England, United Kingdom. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 5, 2017. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9617127
FEI number: 3001139253
Address: Unit D4 Tottenham Commercial Park, Leeside Road, LONDON England, United Kingdom, N17 0QJ
Owner or operator: LIDCO LTD. (9036223)
Roles: Manufacturer
First device listed: January 21, 1999
Registered through: 2026
Brand names listed: LiDCO CNAP Assembly, LiDCO CNAP Module, LiDCO PulseCO Hemodynamic Monitor, LiDCOplus Hemodynamic Monitor, LiDCOrapid v2 Hemodynamic Monitor, LiDCOunity v1 Monitor, LiDCOunity v2 Hemodynamic Monitoring System, LiDCOunity v2 Monitor

Devices it lists

Device	Product code	Class	Role	Source
Computer, Diagnostic, Pre-Programmed, Single-Function	DXG	2	Manufacturer	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 5, 2017	K163334	LiDCOunity v2 Hemodynamic Monitor	DXG	Substantially Equivalent	Lidco, Ltd.	accessdata.fda.gov
March 17, 2016	K152935	LiDCOunity Monitor	DXG	Substantially Equivalent	Lidco, Ltd.	accessdata.fda.gov
August 28, 2013	K131048	LIDCO CNAP MODULE	DXG	Substantially Equivalent	Lidco, Ltd.	accessdata.fda.gov
March 20, 2013	K122247	LIDCORAPID V2 MONITOR	DXG	Substantially Equivalent	Lidco, Ltd.	accessdata.fda.gov
January 9, 2003	K023960	LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70	DXG	Substantially Equivalent	Lidco, Ltd.	accessdata.fda.gov
June 14, 2001	K010049	PULSECO HEMODYNAMIC MONITOR CM71	DXG	Substantially Equivalent	Lidco, Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
November 19, 2020	86825	Class II	Terminated	CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube administrative set).	The expiration date on labeling is incorrect.	accessdata.fda.gov

Compare with other makers

Updated June 5, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.