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

Coloplast A.S. — Predicate Candidate Screening

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

76 daysmedian FDA review time

252 days90th percentile

72clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K262045	Luja Soft	Coloplast A.S.	2026-07-07	20	0
K221874	Altis Single Incision Sling System	Coloplast A/S	2023-02-15	232	0
K220420	Saffron Fixation System	Coloplast A/S	2022-06-10	116	0
K191536	Biatain Silicone Ag	Coloplast A/S	2020-02-21	256	0
K181811	ReTrace Ureteral Access Sheath	Coloplast A/S	2018-09-07	63	0
K173527	Digitex Delivery Device	Coloplast A/S	2018-02-12	90	0
K140310	Peristeen Anal Irrigation System	Coloplast A/S	2015-09-03	573	0
K150935	SpeediCath Compact Eve	Coloplast A/S	2015-07-02	86	0
K150927	Orchestra Hydrophilic Guidewire standard angled, Orchestra H	Coloplast A/S	2015-05-27	51	0
K143182	Speedicath Compact Male	Coloplast A/S	2015-01-20	76	0
K140523	RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM,	Coloplast A/S	2014-07-24	142	0
K140116	RESTORELLE Y CONTOUR MESH	Coloplast A/S	2014-02-12	27	0
K131072	ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA H	Coloplast A/S	2013-07-09	83	0
K123914	RESTORELLE Y CONTOUR	Coloplast A/S	2013-03-05	76	0
K123675	RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND	Coloplast A/S	2013-03-01	91	0
K121562	ALTIS SINGLE INCISION CLING SYSTEM	Coloplast A/S	2012-11-05	160	0
K121458	SPEEDICATH COMPACT SET (12/18 FR)	Coloplast A/S	2012-10-01	138	0
K121833	OSTOMY IRRIGATION SET	Coloplast A/S	2012-07-16	24	0
K112860	PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION	Coloplast A/S	2012-06-08	252	0
K120284	DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE	Coloplast A/S	2012-05-23	113	1
K112322	RESTORELLE POLYPROPYLENE Y MESH	Coloplast A/S	2012-05-17	279	0
K120828	BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X	Coloplast A/S	2012-04-05	17	0
K113496	VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVEN	Coloplast A/S	2012-02-14	81	0
K111881	VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT	Coloplast A/S	2011-08-17	47	0
K111233	SUPRIS RETROPUBIC SLING SYSTEM	Coloplast A/S	2011-06-24	53	0
K103254	PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT,	Coloplast A/S	2011-01-31	89	0
K103568	RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH	Coloplast A/S	2010-12-22	16	1
K102485	RE-TRACE URETERAL ACCESS SHEATH	Coloplast A/S	2010-10-18	49	0
K101297	VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020	Coloplast A/S	2010-06-03	24	0
K100218	BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20C	Coloplast A/S	2010-02-17	22	0
K083770	COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM	Coloplast A/S	2009-11-23	340	0
K083499	EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS	Coloplast A/S	2009-05-08	164	0
K091152	VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020	Coloplast A/S	2009-05-07	17	0
K090217	BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070	Coloplast A/S	2009-04-23	84	0
K953497	COMFEEL:ALGINATE DRESSING	Coloplast A/S	1995-09-29	65	0
K946243	CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER	Coloplast A/S	1995-02-13	53	0
K925376	COMFEEL(R) WOUND DRESSING SD	Coloplast A/S	1993-03-16	144	0
K924406	CONVEEN(R) LEG BAG(500 ML)	Coloplast A/S	1992-10-30	66	0
K924407	CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH	Coloplast A/S	1992-09-23	29	0
K922466	COMFEEL WOUND DRESSING SD	Coloplast A/S	1992-08-17	83	0
K922461	COMFEEL WOUND DRESSING ORD	Coloplast A/S	1992-08-17	83	0
K920925	COMFEEL CONTOUR DRESSING	Coloplast A/S	1992-05-28	90	0
K915246	CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH)	Coloplast A/S	1992-02-05	82	0
K904085	ELLA BREAST FORM	Coloplast A/S	1990-10-31	56	0
K904086	DISCRENE SELF-SUPPORTING BREAST FORM	Coloplast A/S	1990-10-02	27	0
K895548	CONVEEN INTERMITTENT CATHETERS	Coloplast A/S	1990-02-09	149	0
K894916	COMFEEL TRANSPARENT DRESSING	Coloplast A/S	1989-09-26	55	0
K883588	COMPEED ATHLETIC DRESSING	Coloplast A/S	1988-09-22	31	0
K881636	CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)	Coloplast A/S	1988-07-13	90	0
K873669	COMFEEL ULCUS ULCER CARE SYSTEM	Coloplast A/S	1987-11-17	67	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