Caire, Inc.
FDA Regulatory Profile
Caire, Inc. appears in FDA public data with 11 recalls — including 4 Class I (most serious) —, 7 510(k) clearances, 11 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0480-2025, Class II) was initiated on October 4, 2024. Its most recent 510(k) clearance was granted on July 11, 2025.
Summary
- Total Recalls
- 11 (4 Class I)
- 510(k) Clearances
- 7
- Inspections
- 11
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0480-2025 | Class II | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103. | October 4, 2024 |
| Z-0481-2025 | Class II | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2. | October 4, 2024 |
| Z-0479-2025 | Class II | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101. | October 4, 2024 |
| Z-0478-2025 | Class II | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1. | October 4, 2024 |
| Z-0338-2023 | Class I | CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit | October 10, 2022 |
| Z-0339-2023 | Class I | CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit | October 10, 2022 |
| Z-0337-2023 | Class I | CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit | October 10, 2022 |
| Z-0336-2023 | Class I | CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit | October 10, 2022 |
| Z-1117-2022 | Class II | CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #A | March 25, 2022 |
| Z-0805-2020 | Class II | CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Con | November 21, 2019 |
| Z-0248-2020 | Class II | SAROS Oxygen System Model 3000 | September 16, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250671 | FreeStyle Comfort (AS200 / FreeStyle Comfort) | July 11, 2025 |
| K120785 | OMNI 3 OXYGEN SYSTEM | October 25, 2012 |
| K121167 | CAIRE COMPANION 5 OXYGEN CONCENTRATOR | May 2, 2012 |
| K080023 | MODIFICATION TO: SPIRIT | June 16, 2008 |
| K050153 | SPIRIT, MODEL HAS | April 15, 2005 |
| K013251 | SPIRIT 300 | December 18, 2001 |
| K952268 | MODEL DELTA, OM OXYGEN CONCENTRATOR | August 11, 1995 |