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

NAJ · Predicate Candidate Screening

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

180 daysmedian FDA review time

271 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K233813	Bearing nsPVA Express™	Merit Medical Systems, Inc.	2023-12-21	21	0
K173871	CalliSpheres Embolic Microspheres, 8Spheres Embolic Microsph	Suzhou Hengrui Callisyn Biomedical Co., Ltd.	2018-09-17	271	0
K133447	EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-C	Celonova Biosciences, Inc.	2014-02-24	104	0
K130259	BEARING NSPVA EMBOLIZATION PARTICLES	Merit Medical Systems, Inc.	2013-06-07	126	0
K100663	CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600	Boston Scientific Corporation	2010-04-16	39	0
K081768	COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTIC	Cook Incorporated	2008-12-23	186	0
K030966	CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER	Boston Scientific Corp	2003-09-23	180	1
K021397	EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN	Biosphere Medical, Inc.	2002-11-22	204	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