FDA applicant
Cardinal Health, Inc.
FDA records 28 decisions for Cardinal Health, Inc. (Waukegan, IL) from 2006 to 2022: 28 510(k) clearances. Most are in product codes KGO (Surgeon'S Gloves) and LZA (Polymer Patient Examination Glove). Since 2016 its 510(k)s took a median of 160 days from receipt to decision, against 163 for FDA’s reviews in the same codes and years. Its devices cite 36 predicates, 6 of them its own earlier devices. 5 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “Cardinal Health, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cardinal Health, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Cardinal Health, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Cardinal”
FDA records each applicant name separately; these may or may not be the same firm.