510(k) Report

FDA applicant

Buffalo Filter Co., Inc.

E. Amherst, NY24 decisions1993–20171 recall

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, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

2014: 12015: 12017: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Buffalo Filter Co., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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) Report

Other applicant names beginning “Buffalo”

FDA records each applicant name separately; these may or may not be the same firm.