Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Chart IndustriesLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Caire, Inc. with 11 device recalls and 7 510(k) clearances. The most recent is a 510(k) clearance dated Jul 11, 2025: FreeStyle Comfort (AS200 / FreeStyle Comfort).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jul 11, 2025 | FreeStyle Comfort (AS200 / FreeStyle Comfort)K250671 · CAW | 510(k) clearances |
| Oct 4, 2024 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.Class II · Potential failure of affected units to recharge the battery of the oxygen concentrators. | Device recalls |
| Oct 4, 2024 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.Class II · Potential failure of affected units to recharge the battery of the oxygen concentrators. | Device recalls |
| Oct 4, 2024 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.Class II · Potential failure of affected units to recharge the battery of the oxygen concentrators. | Device recalls |
| Oct 4, 2024 | CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.Class II · Potential failure of affected units to recharge the battery of the oxygen concentrators. | Device recalls |
| Oct 10, 2022 | CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System UnitClass I · An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the de | Device recalls |
| Oct 10, 2022 | CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System UnitClass I · An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the de | Device recalls |
| Oct 10, 2022 | CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System UnitClass I · An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the de | Device recalls |
| Oct 10, 2022 | CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System UnitClass I · An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the de | Device recalls |
| Oct 25, 2012 | OMNI 3 OXYGEN SYSTEMK120785 · CAW | 510(k) clearances |
| May 2, 2012 | CAIRE COMPANION 5 OXYGEN CONCENTRATORK121167 · CAW | 510(k) clearances |
| Jun 16, 2008 | MODIFICATION TO: SPIRITK080023 · BYJ | 510(k) clearances |
| Apr 15, 2005 | SPIRIT, MODEL HASK050153 · BYJ | 510(k) clearances |
| Dec 18, 2001 | SPIRIT 300K013251 · BYJ | 510(k) clearances |
| Aug 11, 1995 | MODEL DELTA, OM OXYGEN CONCENTRATORK952268 · CAW | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
