Data / Medical devices / United States / Caire Inc.

Caire Inc.: FDA-registered device maker in Ball Ground, GA, United States, 15 510(k) clearances

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

Caire Inc. is registered with the FDA (registration 3009128734) in Ball Ground, GA, United States. It lists 4 device types. The FDA files 15 510(k) clearances under its listings, the newest dated July 11, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009128734
FEI number: 2129616
Address: 2205 Airport Industrial Dr, Ball Ground, GA, United States, 30107
Owner or operator: CAIRE Inc. (9008476)
Roles: Manufacturer, Repackager or relabeler
First device listed: December 5, 2007
Registered through: 2026
Brand names listed: CR50 Ox Reg and Oxiclip PC20, Companion 1000 and 1000T, Companion 21, 31, and 41, Companion 5 Oxygen Concentrator, Eclipse Oxygen System, Multiple, Focus, FreeStyle, FreeStyle 5 and more

Devices it lists

Device	Product code	Class	Role	Source
Conserver, Oxygen	NFB	2	Manufacturer	accessdata.fda.gov
Flowmeter, Calibration, Gas	BXY	1	Manufacturer	accessdata.fda.gov
Generator, Oxygen, Portable	CAW	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Unit, Liquid-Oxygen, Portable	BYJ	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
July 11, 2025	K250671	FreeStyle Comfort (AS200 / FreeStyle Comfort)	CAW	Substantially Equivalent	Caire, Inc.	accessdata.fda.gov
April 8, 2022	K202389	Oxygen Concentrator	CAW	Substantially Equivalent	Foshan Mic Medical Technology Co., Ltd.	accessdata.fda.gov
May 2, 2012	K121167	CAIRE COMPANION 5 OXYGEN CONCENTRATOR	CAW	Substantially Equivalent	Caire, Inc.	accessdata.fda.gov
October 20, 2009	K083163	OMNI 2 OXYGEN SYSTEM	CAW	Substantially Equivalent	Sequal Technologies, Inc.	accessdata.fda.gov
June 16, 2008	K080023	MODIFICATION TO: SPIRIT	BYJ	Substantially Equivalent	Caire, Inc.	accessdata.fda.gov
March 27, 2002	K013931	OMNI OXYGEN SYSTEM, MODEL 1000	CAW	Substantially Equivalent	Sequal Technologies, Inc.	accessdata.fda.gov
March 13, 2002	K020324	LIFESTYLE OXYGEN CONCENTRATOR	CAW	Substantially Equivalent	Airsep Corp.	accessdata.fda.gov
October 22, 1999	K993220	PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM	BYJ	Substantially Equivalent	Puritan Bennett Corp.	accessdata.fda.gov
February 28, 1997	K960309	AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)	CAW	Substantially Equivalent	Airsep Corp.	accessdata.fda.gov
December 2, 1987	K873901	COMPANION MINI OXYGEN SAVER	NFB	Substantially Equivalent	Puritan Bennett Corp.	accessdata.fda.gov
October 13, 1987	K872534	4LYF OXYGEN CONCENTRATOR	CAW	Substantially Equivalent	Airsep Corp.	accessdata.fda.gov
June 25, 1986	K861503	COMPANION LIQUID OXYGEN SYSTEM	BYJ	Substantially Equivalent	Puritan Bennett Corp.	accessdata.fda.gov
March 20, 1986	K860937	MARK 4 LIQUID OXYGEN SYSTEM	BYJ	Substantially Equivalent	Puritan Bennett Corp.	accessdata.fda.gov
March 10, 1983	K830498	LIQUID OXYGEN SYSTEM	BYJ	Substantially Equivalent	Puritan Bennett Corp.	accessdata.fda.gov
May 23, 1980	K800742	LIBERATOR/STROLLER II SYSTEM	BYJ	Substantially Equivalent	Cryogenic Assoc.	accessdata.fda.gov

Compare with other makers

Updated July 11, 2025. 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.