FDA applicant
Cardinalhealth
FDA records 34 decisions for Cardinalhealth (Waukegan, IL) from 2003 to 2026: 33 510(k) clearances and 1 original PMA approval. Most are in product codes OMP (Negative Pressure Wound Therapy Powered…) and KGO (Surgeon'S Gloves). Since 2016 its 510(k)s took a median of 233 days from receipt to decision, against 137 for FDA’s reviews in the same codes and years. Its devices cite 21 predicates, 4 of them its own earlier devices. 13 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cardinalhealth’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Cardinalhealth’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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