Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardinal Health 207, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
159 daysmedian FDA review time
232 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093094 | VELA VENTILATOR | Cardinal Health 207, Inc. | 2010-05-11 | 222 | 0 |
| K092484 | HELIOX LOW FLOW SENTRY BLENDER | Cardinal Health 207, Inc. | 2010-04-02 | 232 | 0 |
| K093124 | PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM | Cardinal Health 207, Inc. | 2010-03-10 | 159 | 0 |
| K081670 | THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK | Cardinal Health 207, Inc. | 2008-10-09 | 118 | 0 |
| K081837 | AVEA VENTILATOR | Cardinal Health 207, Inc. | 2008-08-13 | 44 | 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