Caire, Inc.

FDA Regulatory Profile

Summary

Total Recalls
11 (4 Class I)
510(k) Clearances
7
Inspections
11
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0481-2025Class IICAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.October 4, 2024
Z-0479-2025Class IICAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.October 4, 2024
Z-0478-2025Class IICAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.October 4, 2024
Z-0480-2025Class IICAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.October 4, 2024
Z-0338-2023Class ICAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System UnitOctober 10, 2022
Z-0339-2023Class ICAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System UnitOctober 10, 2022
Z-0337-2023Class ICAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System UnitOctober 10, 2022
Z-0336-2023Class ICAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System UnitOctober 10, 2022
Z-1117-2022Class IICAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AMarch 25, 2022
Z-0805-2020Class IICAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen ConNovember 21, 2019
Z-0248-2020Class IISAROS Oxygen System Model 3000September 16, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K250671FreeStyle Comfort (AS200 / FreeStyle Comfort)July 11, 2025
K120785OMNI 3 OXYGEN SYSTEMOctober 25, 2012
K121167CAIRE COMPANION 5 OXYGEN CONCENTRATORMay 2, 2012
K080023MODIFICATION TO: SPIRITJune 16, 2008
K050153SPIRIT, MODEL HASApril 15, 2005
K013251SPIRIT 300December 18, 2001
K952268MODEL DELTA, OM OXYGEN CONCENTRATORAugust 11, 1995