Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Wilshire Medical Products · Predicate Candidate Screening

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

65 daysmedian FDA review time

80 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K946030	DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING	Wilshire Medical Products	1995-02-27	80
K946031	DERMASSIST(TM) HYDROGEL SATURATEED NON WOVEN DRESSING	Wilshire Medical Products	1995-02-27	80
K944333	HYDRODERM GEL WOUND DRESSING	Wilshire Medical Products	1994-11-10	65
K941149	DERMAASSIST HYDROCOLLOID DRESSING	Wilshire Medical Products	1994-05-20	71
K941216	HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING	Wilshire Medical Products	1994-05-20	67
K941005	DERMASSIST(TM) XEROFORM PETROLATUM DRESSING	Wilshire Medical Products	1994-04-14	44
K936230	DERMASSIST PETROLATUM GAUZE,USP	Wilshire Medical Products	1994-03-03	64
K936234	DERMASSIST OIL EMULSION NON-ADHERING WOUND DRESSING	Wilshire Medical Products	1994-03-03	64
K940044	DERMASSIST WET DRESSING, SALINE	Wilshire Medical Products	1994-03-03	57
K940076	DERMASSIST WET DRESSING, WATER	Wilshire Medical Products	1994-03-03	56
K935796	HYDRODERM BREATHABLE TRANSPARENT DRESSING	Wilshire Medical Products	1994-02-02	57
K924249	DERMASSIST TRANSPARENT SITE DRESSING	Wilshire Medical Products	1993-02-03	163

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