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

EXB — Predicate Candidate Screening

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

50 daysmedian FDA review time

116 days90th percentile

102clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K252140	Heylo™ System	Coloplast Corp.	2025-10-06	90	0
K181643	SmartBag (SmartPouch)	11 Health Technologies Limited	2018-11-16	147	0
K140938	OSTOM-I ALERT	11 Health and Technologies, LLC	2014-10-10	182	0
K922730	LAKE OSTOMY CARE SET	Lake Medical Products, Inc.	1993-12-30	573	0
K882878	ODOR-END EMERGENCY CLEAN UP POWDER	Cdc Products Corp.	1988-12-08	150	0
K881636	CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)	Coloplast A/S	1988-07-13	90	0
K880306	EMERGENCY-CLEAN UP(TM) ECP	Cdc Products Corp.	1988-05-20	116	0
K872294	COMBINATION NITE DRAINAGE UNIT	Arnold Technologies	1987-12-29	196	0
K873929	'CATCH-IT' OR FECAL CONTAINMENT DEVICE	Midwest Medical Co.	1987-12-03	69	0
K871526	ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER	Cox Family Laboratories, Inc.	1987-10-13	176	0
K871738	OSTO-PURE	Clearchem Corp.	1987-08-12	99	0
K871628	PALEX (R) OSTOMY	Industrias Palex C/O Dma Med-Chem Corp.	1987-07-08	72	0
K870577	E-Z LOOP	John F. Greer Co., Inc.	1987-04-17	66	0
K870531	EZ TAC FILTER	John F. Greer Co., Inc.	1987-04-10	63	0
K870136	PERSONAL PUNCH	Arnold Technologies	1987-04-01	78	0
K864189	ULTRA-GEL - #4083	John F. Greer Co., Inc.	1986-12-04	38	0
K862631	BARD IRYFIX(TM) STOMA CAP	C.R. Bard, Inc.	1986-10-16	98	0
K861070	COLOPLAST CONVEX RING	Coloplast A/S	1986-06-16	88	0
K855019	DURAHESIVE PROTECTIVE BARRIER WIPE	Convatec, A Division of E.R. Squibb & Sons	1986-04-16	121	0
K854726	MEDI-WIPES UNITED ANTISEPTIC SKIN PREP	Pfizer, Inc.	1986-02-24	91	0
K855018	DURAHESIVE WAFER WITH FLANGE	Convatec, A Division of E.R. Squibb & Sons	1986-02-04	50	0
K852471	CONFIDENT ODOR ELIMINATOR	Hallmark Industries, Inc.	1986-01-14	217	0
K851679	OSTOMY BAGS COLOSTOMY	Dbt Medical , Ltd.	1985-06-27	65	0
K851680	OSTOMY BAGS ILEOSTOMY	Dbt Medical , Ltd.	1985-06-27	65	0
K851678	OSTOMY BAGS URETHEROSTOMY	Dbt Medical , Ltd.	1985-06-27	65	0
K851840	STOMAHESIVE SKIN BARRIER STERILE	Convatec, A Division of E.R. Squibb & Sons	1985-06-24	59	0
K852297	JOHNSON & JOHNSON OSTOMY SIZE SELECTOR & BELT	Johnson & Johnson Professionals, Inc.	1985-06-12	14	0
K850750	DISPOSABLE UROSTOMY POUCH	Biolog, Inc.	1985-05-23	87	0
K851398	BARD PERISTOMAL PASTE	C.R. Bard, Inc.	1985-05-23	44	0
K850751	DISPOS. DRAINABEL POUCH FOR ILEOSTOMY/COLOSTOMY	Biolog, Inc.	1985-05-23	87	0
K844938	UNITED SKIN BARRIERS	Pfizer, Inc.	1985-01-18	29	0
K844685	COLOPLAST URO 2002 UROSTOMY SYSTEM	Coloplast A/S	1985-01-08	39	0
K844406	JOHNSON & JOHN SON OSTOMY PASTE PROTECTIVWE SKIN	Johnson & Johnson Professionals, Inc.	1984-11-29	16	0
K844046	UNITED SKIN BARRIERS	Howmedica Corp.	1984-11-29	43	0
K842398	SUR-FIT IRRIGATION ADAPTER FACEPLATE	Convatec, A Division of E.R. Squibb & Sons	1984-10-01	104	0
K842119	OSTOMY OR UROSTOMY ABDOMINAL BELT OS	Atlas Surgical Belt Co., Inc.	1984-09-10	110	0
K841173	OSTOMY FREEDOM KIT	Ellenberg Assoc.	1984-07-09	112	0
K840723	SWEEN-A-PEEL PERISTOMAL WAFERS	Sween Corp.	1984-05-07	76	0
K840568	ACTIVE LIFE ONE-PIECE CLOSED-END POUCH	Convatec, A Division of E.R. Squibb & Sons	1984-05-02	84	2
K840567	ACTIVE LIFE ONE-PIECE STOMA CAP	Convatec, A Division of E.R. Squibb & Sons	1984-05-02	84	0
K833567	COMFEEL PROTECTIVE FILM	Coloplast A/S	1984-05-02	203	0
K841029	BANGORT LIFESTYLE COLOSTOMY POUCHES	Howmedica Corp.	1984-04-04	23	0
K840269	MC 2000 OSTOMY POUCHES	Coloplast A/S	1984-04-02	70	0
K840267	FILTRODER FILTERS	Coloplast A/S	1984-04-02	70	0
K840265	MC 2002 OSTOMY POUCHES & SKIN FLANGES	Coloplast A/S	1984-04-02	70	0
K834575	BARD KARAYA GUM WASHERS	C.R. Bard, Inc.	1984-02-04	37	0
K840166	SUR-FIT UROSTOMY POUCH W/ACCUSEAL	Convatec, A Division of E.R. Squibb & Sons	1984-02-04	19	0
K833565	COMFEEL PASTE	Coloplast A/S	1984-01-30	110	0
K833571	STERILE DRAINAGE SYSTEM	Coloplast A/S	1984-01-30	110	0
K833566	COMFEEL CLEANSER	Coloplast A/S	1983-12-27	76	0

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