Caire, Inc.

Ball Ground, GA, US

CAIRE INC. appears in FDA device records in Ball Ground, GA. FDA records list 2 510(k) clearances between 2012-05-02 and 2025-07-11, no PMA records and 2 registered establishments. As of 2026-09-10, FDA records show 12 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 12
Registered establishments: 2

510(k) clearance history

FDA records hold 2 510(k) clearances for Caire, Inc. between 2012 and 2025. The busiest year on record is 2012, with 1. The most recent is 2025, with 1.

Clearances by year, as a table

510(k) clearance decisions for Caire, Inc., by decision year
Year	Clearances
2012	1
2025	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K250671	FreeStyle Comfort (AS200 / FreeStyle Comfort)	CAW	Substantially Equivalent	2025-07-11
K121167	CAIRE COMPANION 5 OXYGEN CONCENTRATOR	CAW	Substantially Equivalent	2012-05-02

Registered establishments

FDA registered establishments for Caire, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3004972304	3004972304	CAIRE INC.	2200 Airport Industrial Dr Ste 500, Ball Ground, GA 30107 US	2026	BXY BYJ CAW NFB
3009128734	2129616	CAIRE INC.	2205 Airport Industrial Dr, Ball Ground, GA 30107 US	2026	BXY BYJ CAW NFB

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0481-2025	CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.	Potential failure of affected units to recharge the battery of the oxygen concentrators.	Class II	2024-10-04	Completed
Z-0480-2025	CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.	Potential failure of affected units to recharge the battery of the oxygen concentrators.	Class II	2024-10-04	Completed
Z-0479-2025	CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.	Potential failure of affected units to recharge the battery of the oxygen concentrators.	Class II	2024-10-04	Completed
Z-0478-2025	CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.	Potential failure of affected units to recharge the battery of the oxygen concentrators.	Class II	2024-10-04	Completed
Z-0339-2023	CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit	An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.	Class I	2022-10-10	Terminated
Z-0338-2023	CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit	An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.	Class I	2022-10-10	Terminated
Z-0337-2023	CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit	An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.	Class I	2022-10-10	Terminated
Z-0336-2023	CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit	An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.	Class I	2022-10-10	Terminated
Z-1117-2022	CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3	The device was not cleared for U.S. distribution.	Class II	2022-03-25	Terminated
Z-0805-2020	CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.	Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..	Class II	2019-11-21	Terminated
Z-0248-2020	SAROS Oxygen System Model 3000	There is an electronics control issue that causes the unit to not power on with battery power only.	Class II	2019-09-16	Terminated
Z-1716-2008	Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable oxygen unit.	Moisture ingress into the electronic liquid level indicator may cause inaccurate liquid oxygen level readings. The oxygen could run out without the patient knowledge.		2007-10-23	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain