Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Cardinal Health 303,Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091308 | ALARIS PC UNIT, MODELS 8000 AND 8015 | Cardinal Health 303,Inc. | 2009-07-09 | 66 | 0 |
| K072105 | ALARIS SYSTEM WITH MMS, MODEL 8XXX | Cardinal Health 303,Inc. | 2007-12-28 | 150 | 5 |
| K070268 | SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X | Cardinal Health 303,Inc. | 2007-02-23 | 25 | 0 |
| K063288 | SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X | Cardinal Health 303,Inc. | 2006-11-28 | 27 | 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