Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardinal Health 200, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151778 | Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgi | Cardinal Health 200, Inc. | 2016-03-24 | 267 | 0 |
| K150151 | SmartGownTM surgical gown | Cardinal Health 200, Inc. | 2015-05-21 | 118 | 0 |
| K061308 | TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN | Cardinal Health 200, Inc. | 2006-06-05 | 26 | 6 |
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