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

KOZ · Predicate Candidate Screening

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

89 daysmedian FDA review time

210 days90th percentile

22clearances measured

K-number	Device	Applicant	Decided	Review days
K905206	INCARE PINSITE DRESSING	Hollister, Inc.	1991-04-12	143
K905688	CUTINOVA HYDRO	Beiersdorf, Inc.	1991-04-01	103
K905069	IODOSORB GEL	Perstorp AB C/O Robert Joel Slomoff	1991-01-31	83
K904604	REDI-RELEASE ABSORBENT DRESSING	Fountain Pharmaceuticals, Inc.	1991-01-07	89
K896828	BIOCLUSIVE(R) ABSORBENT DRESSING	Johnson & Johnson International	1990-11-21	352
K903645	DERMASORB WOUND CONTACT LAYER DRESSING	Convatec, A Division of E.R. Squibb & Sons	1990-11-21	99
K904412	ALLEVYN DRESSING CLAIMS CHANGE	Smith & Nephew United, Inc.	1990-10-23	27
K901876	INTRASITE CAVITY WOUND DRESSING (LABEL REVISION)	Smith & Nephew United, Inc.	1990-06-28	63
K896176	EXUSORB(TM) DRY/WET DRESSING	Controlled Therapeutics Corp.	1989-11-24	30
K895354	INTRASITE CAVITY WOUND DRESSING	Smith & Nephew United, Inc.	1989-11-07	67
K874552	ENVISAN PAD	Marion Laboratories, Inc.	1988-01-22	79
K872453	DEBRISAN ABSORBENT PAD	Pharmacia, Inc.	1988-01-14	205
K874553	ENVISAN PASTE	Marion Laboratories, Inc.	1987-12-18	44
K872117	DEXTRANOMER	Interworld, Inc.	1987-07-24	53
K870941	PHARMASEAL WOUND CARE DRESSING PAD	American Pharmaseal Div. Ahsc	1987-03-27	18
K870559	IODOSORB POWDER	Perstorp AB C/O Robert Joel Slomoff	1987-03-20	38
K844625	BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY	Bipore, Inc.	1985-01-16	50
K834343	COMFEEL POWDER	Coloplast A/S	1984-11-08	332
K820160	HOLLISTER WOUND EXUDATE ABSORBER	Hollister, Inc.	1982-04-21	91
K800737	DEBRISAN (DEXTRANOMER) PASTE	Pharmaseal Laboratories	1980-08-04	124
K780775	MEDICAL PROTEIN HYDROLYSATE REVITAL	Robertson Resources, Inc.	1978-11-30	210
K760469	CLEANSING AGENT, NEW WOUND (DEBRISSU)	Pharmaseal Laboratories	1976-12-16	119

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