FDA applicant
Epimed International, Inc.
FDA records 16 decisions for Epimed International, Inc. (Johnstown, NY) from 1998 to 2024: 16 510(k) clearances. Most are in product codes BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)) and BSO (Catheter, Conduction, Anesthetic). Its devices cite 19 predicates, 6 of them its own earlier devices. 11 recalls are linked to its devices.
FDA’s records also spell it “Epimed International”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Epimed International, 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 2024
Class I Class II/III not classified
Planning a device like Epimed International, 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