FDA applicant
Devicor Medical Products, Inc.
FDA records 16 decisions for Devicor Medical Products, Inc. (Cincinnati, OH) from 2012 to 2026: 16 510(k) clearances. Most are in product codes NEU (Marker, Radiographic, Implantable) and KNW (Instrument, Biopsy). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 127 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 10 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Devicor Medical Products, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2024
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Devicor Medical Products, 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