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

HBA — Predicate Candidate Screening

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

113 daysmedian FDA review time

360 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K193346	Codman Surgical Patties & Strips	Integra LifeSciences Corporation	2020-11-20	353	23
K140369	MEDLINE NEURO SPONGE	Medline Industries, Inc.	2014-09-26	224	2
K112598	AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)	American Surgical Company, LLC	2013-06-20	652	0
K121822	DELICOT	American Surgical Company, LLC	2012-09-10	81	0
K073576	NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUR	Harod Enterprises, Inc.	2008-02-22	65	0
K062406	AESCULAP NEURO PATTIES	Aesculap, Inc.	2006-09-15	29	0
K031008	AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHIT	Aesculap	2003-05-09	39	0
K020736	TRAATEK COTTONOID PATTIES	Traatek, Inc.	2002-06-03	89	0
K014268	NORAPAD PLAIN; NORAPAD TA	Perlei Medical, Inc.	2002-03-27	90	0
K993019	PACIFIC SURGICAL PATTIES	V. Mueller Neuro/Spine	2000-03-30	204	0
K973083	ULTRACELL NEURO SPONGES	Ultracell Medical Technologies, Inc.	1997-12-09	113	0
K962807	AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES	American Surgical Sponges	1997-05-02	288	0
K970328	ULTRACELL NEURO SPONGES	Ultracell Medical Technologies, Inc.	1997-04-21	84	0
K950647	ULTRACELL NEURO SPONGES	Ultracell Medical Technologies, Inc.	1995-08-15	183	0
K914600	NEUROLOGICAL SPONGE	I M, Inc.	1992-12-30	446	0
K923027	NEURAY SURGICAL PATTIES AND STRIPS	Martland Healthcare, Inc.	1992-08-28	66	0
K904514	STRUNG TELFA NON-ADHERENT SPONGE	American Silk Sutures, Inc.	1991-03-27	176	0
K902921	RAYON NEUROLOGICAL SPONGE	American Silk Sutures, Inc.	1990-09-18	77	0
K891993	COLLAGEN NEUROSPONGE	Vitaphore Corp.	1990-03-23	360	0
K880402	CODMAN SURGICAL PATTIE	Codman & Shurtleff, Inc.	1988-03-02	33	3
K862494	POLYESTER SPONGE PATTIE	American Silk Sutures, Inc.	1986-07-30	29	0
K854713	COTTON NEUROLOGICAL SPONGE	American Silk Sutures, Inc.	1986-03-20	118	0
K844594	NEURO CUSTOM SURGICAL KIT	Xanmed Corp.	1985-06-13	199	0
K770894	NEURO-SORB PATTIES	Instranetics, Inc.	1977-06-20	35	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