Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardinal Health, LLC · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221603 | Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ | Cardinal Health, LLC | 2022-12-20 | 201 | 0 |
| K211765 | Cardinal Health RoyalSilk Surgical Gown, Cardinal Health Roy | Cardinal Health, LLC | 2021-11-23 | 168 | 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