FDA applicant
Cardinal Health200, LLC
FDA records 26 decisions for Cardinal Health200, LLC (Waukegan, IL) from 2011 to 2024: 26 510(k) clearances. Most are in product codes FRG (Wrap, Sterilization) and FYA (Gown, Surgical). Since 2016 its 510(k)s took a median of 118 days from receipt to decision, against 137 for FDA’s reviews in the same codes and years. Its devices cite 27 predicates, 13 of them its own earlier devices. 23 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cardinal Health200, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
4in 2025
Class I Class II/III not classified
Planning a device like Cardinal Health200, LLC’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.