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

BSN — Predicate Candidate Screening

9 FDA 510(k) clearances under this product code; the 50 most recent screened below.

121 daysmedian FDA review time

393 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K190663	Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit	PAJUNK GmbH Medizintechnologie	2019-06-17	94	0
K133004	VENTED MILLEX -GV, CATHIVEX -GV	Merck Millipore , Ltd.	2014-03-27	183	0
K083451	PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD	Smiths Medical Asd, Inc.	2009-03-04	103	0
K023892	MILLEX VV, GV, AND HV SYRINGE FILTER UNITS	Millipore Corp.	2003-01-17	56	1
K013988	MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R	Millipore Corp.	2002-04-04	121	0
K963717	MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS)	Millipore Corp.	1997-06-10	267	0
K960928	SYRINGEFILTER	Arbor Technologies, Inc.	1997-04-04	393	0
K902666	ANESTHESIA CONDUCTION FILTER	Arbor Technologies, Inc.	1991-04-23	309	0
K780519	FILTER TUBE	Jelco Laboratories	1978-05-09	39	0

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