Data / Medical devices / United States / Criticare Technologies, Inc.

Criticare Technologies, Inc.: FDA-registered device maker in Warwick, RI, United States, 5 510(k) clearances

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

Criticare Technologies, Inc. is registered with the FDA (registration 3012238587) in Warwick, RI, United States. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 1, 2010. 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: 3012238587
Address: 333 Strawberry Field Rd Suite 11, Warwick, RI, United States, 02886
Owner or operator: Criticare Technologies, Inc. (10051461)
Roles: Manufacturer, Repackager or relabeler
First device listed: March 22, 2016
Registered through: 2026
Brand names listed: Poet IQ / nCompass, Vitalcare / eQuality, eQuality, eVision, nGenuity

Devices it lists

Device	Product code	Class	Role	Source
Detector And Alarm, Arrhythmia	DSI	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Monitor, St Segment With Alarm	MLD	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Oximeter	DQA	2	Manufacturer, Repackager or relabeler	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
September 1, 2010	K101602	VITAL SIGNS MONITOR	MLD	Substantially Equivalent	Criticare Systems, Inc.	accessdata.fda.gov
May 27, 2009	K091050	506CN PATIENT MONITOR	DRT	Substantially Equivalent	Criticare Systems, Inc.	accessdata.fda.gov
April 17, 2003	K030613	VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100	MHX	Substantially Equivalent	Criticare Systems, Inc.	accessdata.fda.gov
August 1, 2001	K012059	8100/8500 VITAL SIGNS MONITOR	MWI	Substantially Equivalent	Criticare Systems, Inc.	accessdata.fda.gov
March 16, 1989	K884216	506 NON-INVASIVE VITAL SIGNS MONITOR	DSI	Substantially Equivalent	Criticare Systems, Inc.	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
May 6, 2026	99545	Class II	Ongoing	nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100EP1-US, CAT 8100EP1R	Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.	accessdata.fda.gov

Compare with other makers

Updated September 22, 2026. 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.