Company ยท US
Caire, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2025. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
12recalls (0 in 12 months)
8recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 11, 2025 | K250671 | FreeStyle Comfort (AS200 / FreeStyle Comfort) Caire, Inc. | CAW |
| Oct 25, 2012 | K120785 | OMNI 3 OXYGEN SYSTEM Caire, Inc. | CAW |
| May 2, 2012 | K121167 | CAIRE COMPANION 5 OXYGEN CONCENTRATOR Caire, Inc. | CAW |
| Jun 16, 2008 | K080023 | MODIFICATION TO: SPIRIT Caire, Inc. | BYJ |
| Apr 15, 2005 | K050153 | SPIRIT, MODEL HAS Caire, Inc. | BYJ |
| Dec 18, 2001 | K013251 | SPIRIT 300 Caire, Inc. | BYJ |
| Aug 11, 1995 | K952268 | MODEL DELTA, OM OXYGEN CONCENTRATOR Caire, Inc. | CAW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2024 | Caire, Inc. CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2. Completed |
CAW | None listed |
| Nov 15, 2024 | Caire, Inc. CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103. Completed |
CAW | None listed |
| Nov 15, 2024 | Caire, Inc. CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101. Completed |
CAW | K020324 |
| Nov 15, 2024 | Caire, Inc. CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1. Completed |
CAW | K020324 |
| Dec 2, 2022 | Caire, Inc. CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit Terminated |
BYJ | K800742 |
| Dec 2, 2022 | Caire, Inc. CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit Terminated |
BYJ | K800742 |
| Dec 2, 2022 | Caire, Inc. CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit Terminated |
BYJ | K800742 |
| Dec 2, 2022 | Caire, Inc. CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit Terminated |
BYJ | K800742 |
| Mar 25, 2022 | Caire, Inc. CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3 Terminated |
CAW | None listed |
| Nov 21, 2019 | Caire, Inc. 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 Terminated |
CAW | None listed |
| Sep 16, 2019 | Caire, Inc. SAROS Oxygen System Model 3000 Terminated |
CAW | K083163 |
| Aug 26, 2008 | Caire, Inc. Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable oxygen unit. Terminated |
BYJ | K050153 |