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

KOX — Predicate Candidate Screening

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

118 daysmedian FDA review time

201 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K934790	SEPP ADHESIVE REMOVER	Medi-Flex Hospital Products, Inc.	1994-03-11	157
K931933	CHAD LABS ADHESIVE BANDAGE REMOVER	Chad Labs Corp.	1993-07-08	80
K924976	ALLKARE(TM) ADHESIVE REMOVER WIPE	Convatec, A Division of E.R. Squibb & Sons	1993-04-20	201
K924571	MEDI-SOL	Orange-Sol, Inc.	1993-04-06	208
K925618	3M REMOVER LOTION PRODUCT NUMBER 86XX	3M Health Care, Ltd.	1993-03-31	145
K923351	SKIN SUPPORT PREP PAD	Coloplast Corp.	1992-09-14	68
K915150	REMOVE ADHESIVE REMOVER	Smith & Nephew United, Inc.	1992-01-09	56
K902009	ELANTEC'S SURGICAL TAPE REMOVER	Elantec, Inc.	1990-08-29	118
K895293	KEMI LABS - ADHESIVE BANDAGE REMOVER	Kemi Labs, Inc.	1990-02-09	168
K893603	REMOVE ADHESIVE REMOVER	Smith & Nephew United, Inc.	1989-07-14	59
K881359	DECALCIFYING SOLUTION II	Stephens Scientific	1988-04-19	19
K821162	ADHESIVE REMOVER	The Healthcare Group Laboratories, Inc.	1982-05-14	18

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