FDA applicant
Buffalo Filter Co., Inc.
FDA records 24 decisions for Buffalo Filter Co., Inc. (E. Amherst, NY) from 1993 to 2017: 24 510(k) clearances. Most are in product codes FYD (Apparatus, Exhaust, Surgical) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 4 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Buffalo Filter, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Buffalo Filter Co., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Buffalo Filter Co., 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 “Buffalo”
FDA records each applicant name separately; these may or may not be the same firm.