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

Puricore, Inc. — Predicate Candidate Screening

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

136 daysmedian FDA review time

308 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K141863	PURICORE WOUND HYDROGEL SPRAY DRESSING	Puricore, Inc.	2015-05-14	308
K131848	VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ)	Puricore, Inc.	2014-03-31	283
K123072	VASHE WOUND THERAPY SOLUTION	Puricore, Inc.	2013-02-14	136
K123071	VASHE SKIN AND WOUND HYDROGEL	Puricore, Inc.	2013-01-24	115
K100918	VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014	Puricore, Inc.	2010-08-09	129
K093697	VASHE WOUND THERAPY SOLUTION	Puricore, Inc.	2010-04-13	134
K093155	VASHE WOUND CLEANSING SYSTEM	Puricore, Inc.	2010-03-01	146
K092232	MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-001	Puricore, Inc.	2009-08-19	27
K063159	STERILOX LIQUID CHEMICAL STERILANT SYSTEM	Puricore, Inc.	2007-04-02	167
K061689	AQUATINE EC ENDODONTIC CLEANSER	Puricore, Inc.	2006-08-24	70

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