Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Buffalo Filter Co., Inc. — Predicate Candidate Screening

22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

310 daysmedian FDA review time
356 days90th percentile
22clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K131402VISICLEAR SMOKE EVACUATION SYSTEMBuffalo Filter Co., Inc.2014-03-032920
K000904PENADAPT 10Buffalo Filter Co., Inc.2000-06-08790
K983298BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFABuffalo Filter Co., Inc.1999-08-163291
K983333BUFFALO FILTER VIROSAFE HRF- #VSHRFO1Buffalo Filter Co., Inc.1999-08-113220
K983364BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801Buffalo Filter Co., Inc.1999-08-113210
K943226BUFFALO FILTER REPLACEMENT FILTER #BSPF030Buffalo Filter Co., Inc.1995-07-103690
K943227BUFFALO FILTER REPLACEMENT FILTER #BSUCF03Buffalo Filter Co., Inc.1995-07-073660
K930058BUFFALO FILTER REPLACEMENT FILTER #BPTU100Buffalo Filter Co., Inc.1993-11-303280
K930062BUFFALO FILTER REPLACEMENT FILTER #BST300ULBuffalo Filter Co., Inc.1993-11-303280
K930067BUFFALO FILTER SURGICAL MASKBuffalo Filter Co., Inc.1993-11-303280
K930063BUFFALO FILTER REPLACEMENT FILTER #BCULPABuffalo Filter Co., Inc.1993-11-123100
K930066BUFFALO FILTER REPLACEMENT FILTER #BCCHARBuffalo Filter Co., Inc.1993-11-123100
K930064BUFFALO FILTER REPLACEMENT FILTER #BCR0030Buffalo Filter Co., Inc.1993-11-123100
K930060BUFF. FILTER REPLACEMENT FILTER #BST312CO,BST306COBuffalo Filter Co., Inc.1993-11-123100
K930065BUFFALO FILTER REPLACEMENT FILTER #BCR0043Buffalo Filter Co., Inc.1993-11-123100
K930041VICROSAFE 6 AND VICROSAFE 12Buffalo Filter Co., Inc.1993-11-033020
K930040BUFFALO FILTER REPLACEMENT #BLFS-101/103Buffalo Filter Co., Inc.1993-11-023010
K930061BUFFALO FILTER REPLACEMENT FILTER BST312PFBuffalo Filter Co., Inc.1993-11-023000
K930059BUFFALO FILTER REPLACEMENT FILTER #BSTM300Buffalo Filter Co., Inc.1993-10-292960
K930450BUFFALO FILTER REPLACEMENT FILTER #BILF-100Buffalo Filter Co., Inc.1993-10-292970
K924731PLUMESAFE(TM) 1201 SMOKE EVACUATION SYSTEMBuffalo Filter Co., Inc.1993-09-133560
K924732PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEMBuffalo Filter Co., Inc.1993-09-133560

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda