Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Cardinal Health-Medical Products and Services · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
129 daysmedian FDA review time
163 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132060 | DURABLUE STERILIZATION WRAP | Cardinal Health-Medical Products and Services | 2013-12-13 | 163 | 0 |
| K123289 | DURABLUE STERILIZATION WRAP | Cardinal Health-Medical Products and Services | 2013-02-28 | 129 | 0 |
| K120542 | CARDINAL HEALTH DURABLUE STERILIZATION WRAP | Cardinal Health-Medical Products and Services | 2012-06-01 | 99 | 0 |
| K113707 | STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE CO | Cardinal Health-Medical Products and Services | 2012-04-27 | 133 | 0 |
| K111868 | STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH N | Cardinal Health-Medical Products and Services | 2011-09-21 | 82 | 0 |
| K983962 | ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVES | Cardinal Health,Medical Products and Services | 1999-01-08 | 63 | 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