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

Vitaphore Corp. — Predicate Candidate Screening

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

91 daysmedian FDA review time

360 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K914579	SILVER FOAM WOUND DRESSING	Vitaphore Corp.	1992-02-21	128
K913148	COLLAGEN SHIELD FOR ACUTE CARE	Vitaphore Corp.	1991-10-15	91
K895920	VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS	Vitaphore Corp.	1991-06-06	603
K902558	COLLAGEN SHIELD FOR ACUTE CARE	Vitaphore Corp.	1990-08-17	67
K891993	COLLAGEN NEUROSPONGE	Vitaphore Corp.	1990-03-23	360
K896455	VITACHOICE WOUND DRESSING	Vitaphore Corp.	1990-02-15	98
K896046	VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE	Vitaphore Corp.	1990-01-11	86
K895993	VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE	Vitaphore Corp.	1990-01-11	90
K890435	VITAACCESS CATHETER INTRODUCER KIT	Vitaphore Corp.	1989-03-29	61
K882100	VITACUFF(R) PERCUTANEOUS INFECT. CONTROL KIT	Vitaphore Corp.	1988-07-13	55
K872998	VITAACCESS (TM) CATHETER INTRODUCER SYSTEM	Vitaphore Corp.	1988-03-24	234
K872538	VITAPATCH PIN PROTECTION DEVICE FOR PERCUT. PINS	Vitaphore Corp.	1987-07-10	11
K861563	VITAGUARD PERCUTANEOUS INFECTION CONTROL KIT	Vitaphore Corp.	1986-08-27	124

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