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

Convatec, A Division of E.R. Squibb & Sons · Predicate Candidate Screening

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

73 daysmedian FDA review time

238 days90th percentile

81clearances measured

K-number	Device	Applicant	Decided	Review days
K013814	ABSORBENT ANTIMICROBIAL WOUND DRESSING	Convatec, A Division of E.R. Squibb & Sons	2002-06-21	217
K990964	SIGNADRESS DUODERM DRESSING	Convatec, A Division of E.R. Squibb & Sons	1999-05-18	56
K984388	HA ABSORBENT WOUND DRESSING	Convatec, A Division of E.R. Squibb & Sons	1999-03-03	85
K980720	NONWOVEN PAD	Convatec, A Division of E.R. Squibb & Sons	1998-04-15	50
K980382	NON-WOVEN COMPRESS	Convatec, A Division of E.R. Squibb & Sons	1998-03-09	35
K974823	NONWOVEN DRESSING	Convatec, A Division of E.R. Squibb & Sons	1998-02-20	58
K974205	KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON	Convatec, A Division of E.R. Squibb & Sons	1998-02-06	88
K974304	GERMICIDAL CLOTH	Convatec, A Division of E.R. Squibb & Sons	1998-01-13	57
K973632	DUODERM CGF CONTROL GEL FORMULA DRESSING	Convatec, A Division of E.R. Squibb & Sons	1997-12-22	89
K972530	CONVATEC ODOR CONTROL WOUND DRESSING	Convatec, A Division of E.R. Squibb & Sons	1997-10-01	86
K972062	CONVATEC NON-ADHESIVE DRESSING	Convatec, A Division of E.R. Squibb & Sons	1997-08-14	72
K964835	COVERAGE SPRAY HBV	Convatec, A Division of E.R. Squibb & Sons	1996-12-16	21
K964749	COVERAGE HBV	Convatec, A Division of E.R. Squibb & Sons	1996-12-13	17
K963265	PROSYS SAMEC LA	Convatec, A Division of E.R. Squibb & Sons	1996-10-25	66
K962739	T.B.Q.	Convatec, A Division of E.R. Squibb & Sons	1996-10-07	84
K962590	SIGNALDRESS	Convatec, A Division of E.R. Squibb & Sons	1996-09-20	80
K962604	PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET	Convatec, A Division of E.R. Squibb & Sons	1996-07-18	16
K961319	EPIVIEW	Convatec, A Division of E.R. Squibb & Sons	1996-07-08	94
K953767	PROSYS BEDSIDE DRAINAGE BAG	Convatec, A Division of E.R. Squibb & Sons	1995-12-20	131
K952208	PROSYS LEG BAG	Convatec, A Division of E.R. Squibb & Sons	1995-08-15	97
K951022	CIRCULON SYSTEM STEP 1	Convatec, A Division of E.R. Squibb & Sons	1995-06-12	97
K951021	CIRCULON SYSTEM STEP 2	Convatec, A Division of E.R. Squibb & Sons	1995-06-12	97
K951945	PROSYS LEG BAG	Convatec, A Division of E.R. Squibb & Sons	1995-05-25	29
K951530	PROSYS URIHESIVE SYSTEM LA	Convatec, A Division of E.R. Squibb & Sons	1995-05-12	39
K950690	PROSYS URIHESICE SYSTEM NL	Convatec, A Division of E.R. Squibb & Sons	1995-03-23	37
K943258	HYDROCOLLOID WOUND DRESSING	Convatec, A Division of E.R. Squibb & Sons	1994-08-04	29
K935948	CONVATEC TWO PIECE ABSORBENT DRESSING SYSTEM	Convatec, A Division of E.R. Squibb & Sons	1994-03-01	78
K925004	ALLKARE BARRIER WIPE	Convatec, A Division of E.R. Squibb & Sons	1994-01-12	467
K932101	DUODERM IMPROVED CGF CONTROL GEL FORMULA DRESSING	Convatec, A Division of E.R. Squibb & Sons	1993-12-27	238
K926230	EPIDRESS & DERMASORB HYDROCOLLOID ALGINATE DRESSIN	Convatec, A Division of E.R. Squibb & Sons	1993-12-23	377
K931618	DUODERM HYDROCOLLOID GEL	Convatec, A Division of E.R. Squibb & Sons	1993-12-10	252
K932143	FLEXI-TRAK ANCHORING DEVICE	Convatec, A Division of E.R. Squibb & Sons	1993-12-01	215
K925991	DUODERM CGF CONTROL GEL FORMULA DRESSING & BORDER	Convatec, A Division of E.R. Squibb & Sons	1993-10-28	337
K925993	DUODERM HYDROACTIVE DRESSING	Convatec, A Division of E.R. Squibb & Sons	1993-10-28	337
K925990	DUODERM EXTRA THIN CGF DRESSING	Convatec, A Division of E.R. Squibb & Sons	1993-10-28	337
K925992	DUODERM TRANSPARENT HYDROCOLLOID DRESSING	Convatec, A Division of E.R. Squibb & Sons	1993-10-15	324
K924755	CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION	Convatec, A Division of E.R. Squibb & Sons	1993-06-22	272
K924976	ALLKARE(TM) ADHESIVE REMOVER WIPE	Convatec, A Division of E.R. Squibb & Sons	1993-04-20	201
K920675	DUODERM SUSTAINED COMPRESSION BANDAGE	Convatec, A Division of E.R. Squibb & Sons	1992-08-18	186
K915616	URIHESIVE STRIP	Convatec, A Division of E.R. Squibb & Sons	1992-01-23	38
K912518	CIRCULON(TM) ADHESIVE COMPRESSION BANDAGE	Convatec, A Division of E.R. Squibb & Sons	1991-09-04	90
K912667	DUODERM HYDROACTIVE DRESSING AND CGF DRESSINGS	Convatec, A Division of E.R. Squibb & Sons	1991-09-04	78
K912550	DUODERM(R) ADHESIVE COMPRESSION BANDAGE, MODIFIED	Convatec, A Division of E.R. Squibb & Sons	1991-08-14	65
K904233	CONVATEC ABSORBENT BANDAGE	Convatec, A Division of E.R. Squibb & Sons	1991-03-06	182
K904852	DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK	Convatec, A Division of E.R. Squibb & Sons	1991-01-25	88
K905128	FLEXI-TRAK(TM) ANCHORING DEVICE	Convatec, A Division of E.R. Squibb & Sons	1990-11-29	15
K903645	DERMASORB WOUND CONTACT LAYER DRESSING	Convatec, A Division of E.R. Squibb & Sons	1990-11-21	99
K901155	DUODERM* CONTROL GEL FORMULA BORDER DRESSING	Convatec, A Division of E.R. Squibb & Sons	1990-04-16	34
K900447	DUODERM* ADHESIVE COMPRESSION BANDAGE	Convatec, A Division of E.R. Squibb & Sons	1990-04-13	73
K895376	ACTIDERM (TM) DERMATOLOGICAL PATCH	Convatec, A Division of E.R. Squibb & Sons	1989-09-25	26

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