FDA applicant
Inter-Med, Inc.
FDA records 12 decisions for Inter-Med, Inc. (Racine, WI) from 1984 to 2026: 12 510(k) clearances. Most are in product codes KJJ (Cleanser, Root Canal) and KIF (Resin, Root Canal Filling). Since 2016 its 510(k)s took a median of 175 days from receipt to decision, against 151 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 0 of them its own earlier devices. 7 recalls are linked to its devices.
FDA’s records also spell it “Inter-Med Corp.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Inter-Med, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
7in 2019
Class I Class II/III not classified
Planning a device like Inter-Med, 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 “Inter-Med”
FDA records each applicant name separately; these may or may not be the same firm.