Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Caire, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
224 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250671 | FreeStyle Comfort (AS200 / FreeStyle Comfort) | Caire, Inc. | 2025-07-11 | 128 | 0 |
| K120785 | OMNI 3 OXYGEN SYSTEM | Caire, Inc. | 2012-10-25 | 224 | 0 |
| K121167 | CAIRE COMPANION 5 OXYGEN CONCENTRATOR | Caire, Inc. | 2012-05-02 | 15 | 0 |
| K080023 | MODIFICATION TO: SPIRIT | Caire, Inc. | 2008-06-16 | 164 | 0 |
| K050153 | SPIRIT, MODEL HAS | Caire, Inc. | 2005-04-15 | 81 | 1 |
| K013251 | SPIRIT 300 | Caire, Inc. | 2001-12-18 | 81 | 0 |
| K952268 | MODEL DELTA, OM OXYGEN CONCENTRATOR | Caire, Inc. | 1995-08-11 | 88 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda