FDA applicant
Case Medical, Inc.
FDA records 16 decisions for Case Medical, Inc. (Ridgefield, NJ) from 1997 to 2026: 16 510(k) clearances. Most are in product codes FRG (Wrap, Sterilization) and KCT (Sterilization Wrap Containers, Trays…). Since 2016 its 510(k)s took a median of 246 days from receipt to decision, against 137 for FDA’s reviews in the same codes and years. Its devices cite 21 predicates, 16 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Case Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Case Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2013
Class I Class II/III not classified
Planning a device like Case Medical, 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 “Case”
FDA records each applicant name separately; these may or may not be the same firm.