Buffalo Filter Co., Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Buffalo Filter Co., Inc.” (first 1993, latest 2017), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 310 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 292 |
| 2015 | 1 | 96 |
| 2016 | 0 | — |
| 2017 | 1 | 30 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Buffalo Filter Co., Inc. took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 125 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FYD | Apparatus, Exhaust, Surgical | 21 | 21 |
| FXX | Mask, Surgical | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
Review panels
Most recent Buffalo Filter Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171139 | LaparoLight Veress Needle | HIF | 2017-05-18 | 30 |
| K150569 | LaparoVue | GCJ | 2015-06-10 | 96 |
| K131402 | VISICLEAR SMOKE EVACUATION SYSTEM | FYD | 2014-03-03 | 292 |
| K000904 | PENADAPT 10 | FYD | 2000-06-08 | 79 |
| K983298 | BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF | FYD | 1999-08-16 | 329 |
| K983364 | BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801 | FYD | 1999-08-11 | 321 |
| K983333 | BUFFALO FILTER VIROSAFE HRF- #VSHRFO1 | FYD | 1999-08-11 | 322 |
| K943226 | BUFFALO FILTER REPLACEMENT FILTER #BSPF030 | FYD | 1995-07-10 | 369 |
| K943227 | BUFFALO FILTER REPLACEMENT FILTER #BSUCF03 | FYD | 1995-07-07 | 366 |
| K930067 | BUFFALO FILTER SURGICAL MASK | FXX | 1993-11-30 | 328 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Buffalo Filter Co., Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Buffalo Dental Mfg. Co., Inc. (11 510(k)s)
- Buffalo Medical Specialties Mfg., Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Buffalo Filter Co., Inc.?
FDA lists 24 510(k) clearances under the applicant name “Buffalo Filter Co., Inc.” (first 1993, latest 2017), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Buffalo Filter Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Buffalo Filter Co., Inc. is 310 days.
Which FDA product codes appear under Buffalo Filter Co., Inc.?
The most frequent FDA product codes under this applicant name are FYD (Apparatus, Exhaust, Surgical, 21); FXX (Mask, Surgical, 1); GCJ (Laparoscope, General & Plastic Surgery, 1).
Next steps
- See all 24 Buffalo Filter Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code FYD, Buffalo Filter Co., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.