Data / Medical devices / United States / Caire Inc.
Caire Inc.: FDA-registered device maker in Ball Ground, GA, United States, 16 510(k) clearances
Caire Inc. is registered with the FDA (registration 3004972304) in Ball Ground, GA, United States. It lists 4 device types. The FDA files 16 510(k) clearances under its listings, the newest dated July 11, 2025. 6 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004972304
- Address
- 2200 Airport Industrial Dr Ste 500, Ball Ground, GA, United States, 30107
- Owner or operator
- CAIRE Inc. (9008476)
- Roles
- Repackager or relabeler, Specification developer
- 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 | Specification developer | accessdata.fda.gov |
| Flowmeter, Calibration, Gas | BXY | 1 | Specification developer | accessdata.fda.gov |
| Generator, Oxygen, Portable | CAW | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Unit, Liquid-Oxygen, Portable | BYJ | 2 | Specification developer | 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 28, 2023 | K213825 | Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A | CAW | Substantially Equivalent | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 4, 2024 | 95576 | Class II | Completed | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1. | Potential failure of affected units to recharge the battery of the oxygen concentrators. | accessdata.fda.gov |
| October 10, 2022 | 90999 | Class I | Terminated | 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. | accessdata.fda.gov |
| March 25, 2022 | 90011 | Class II | Terminated | CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3 | The device was not cleared for U.S. distribution. | accessdata.fda.gov |
| November 21, 2019 | 84512 | Class II | Terminated | 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 doe | Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US.. | accessdata.fda.gov |
| September 16, 2019 | 83850 | Class II | Terminated | SAROS Oxygen System Model 3000 | There is an electronics control issue that causes the unit to not power on with battery power only. | accessdata.fda.gov |
| October 23, 2007 | 47468 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Generator, Oxygen, Portable
- All makers of Conserver, Oxygen
- All makers of Unit, Liquid-Oxygen, Portable
- All makers of Flowmeter, Calibration, Gas
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.