FDA applicant
Applied Medical Technology, Inc.
FDA records 25 decisions for Applied Medical Technology, Inc. (Brecksville, OH) from 1998 to 2026: 25 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and KGC (Tube, Gastro-Enterostomy). Since 2016 its 510(k)s took a median of 150 days from receipt to decision, against 138 for FDA’s reviews in the same codes and years. Its devices cite 23 predicates, 7 of them its own earlier devices. 12 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Applied Medical Technology, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
6in 2025
Class I Class II/III not classified
Planning a device like Applied Medical Technology, 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) Report