Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Coloplast Corp. — Predicate Candidate Screening
54 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
262 days90th percentile
54clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252140 | Heylo™ System | Coloplast Corp. | 2025-10-06 | 90 | 0 |
| K251116 | Luja Coudé | Coloplast Corp. | 2025-06-27 | 77 | 0 |
| K250270 | Luja Set | Coloplast Corp. | 2025-04-17 | 77 | 0 |
| K242049 | SureCath Set | Coloplast Corp. | 2024-11-26 | 137 | 0 |
| K241210 | Luja Coude | Coloplast Corp. | 2024-11-21 | 205 | 0 |
| K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL | Coloplast Corp. | 2024-11-12 | 111 | 0 |
| K242473 | Altis Single Incision Sling System (519650); Aris Transobtur | Coloplast Corp. | 2024-10-18 | 59 | 0 |
| K233411 | Folysil Silicone Catheter | Coloplast Corp. | 2024-04-15 | 192 | 1 |
| K231953 | Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatai | Coloplast Corp. | 2024-03-22 | 266 | 0 |
| K233101 | Luja Coude (20108 Male CH18 - large packaging) | Coloplast Corp. | 2023-10-26 | 30 | 0 |
| K213185 | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyel | Coloplast Corp. | 2022-06-08 | 252 | 0 |
| K211911 | Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutan | Coloplast Corp. | 2022-03-10 | 262 | 0 |
| K213186 | NovoFlow Reinforced Ureteral Stent | Coloplast Corp. | 2022-02-16 | 140 | 0 |
| K201436 | Vortek Single Loop Ureteral Stent | Coloplast Corp. | 2021-02-25 | 269 | 0 |
| K201165 | In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz She | Coloplast Corp. | 2020-12-17 | 230 | 0 |
| K201007 | In-Ka Ureteral Balloon Dilatation Catheter | Coloplast Corp. | 2020-06-11 | 55 | 0 |
| K182831 | SabreLine and SabreGuard Laser Fibers | Coloplast Corp. | 2018-12-10 | 62 | 0 |
| K180469 | ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent | Coloplast Corp. | 2018-11-06 | 258 | 0 |
| K182122 | Ureteric Catheters | Coloplast Corp. | 2018-10-04 | 59 | 0 |
| K180057 | VORTEK URETERAL DOUBLE LOOP STENT | Coloplast Corp. | 2018-03-09 | 60 | 0 |
| K171043 | Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hyd | Coloplast Corp. | 2017-12-21 | 258 | 0 |
| K170362 | VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS | Coloplast Corp. | 2017-11-15 | 282 | 0 |
| K170422 | BIOSOFT DUO DOUBLE LOOP URETERAL STENTS | Coloplast Corp. | 2017-11-02 | 262 | 0 |
| K170531 | Ureteral Dilators and Percutaneous Nephrostomy Dilators | Coloplast Corp. | 2017-08-17 | 176 | 1 |
| K161672 | SpeediCath Flex Coude | Coloplast Corp. | 2016-09-29 | 112 | 0 |
| K132061 | RESTORELLE M, RESTORELLE XL | Coloplast Corp. | 2013-08-02 | 30 | 0 |
| K122968 | NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL | Coloplast Corp. | 2012-12-18 | 84 | 0 |
| K122440 | RESTORELLE L | Coloplast Corp. | 2012-11-19 | 101 | 1 |
| K121457 | SPEEDICATH COMPACT SET (12 FR) | Coloplast Corp. | 2012-10-02 | 139 | 0 |
| K112386 | EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM | Coloplast Corp. | 2011-09-08 | 21 | 0 |
| K072808 | SPEEDICATH COMPACT | Coloplast Corp. | 2007-11-09 | 39 | 0 |
| K052229 | COLOPLAST OSTOMY ROD, MODEL 12814 | Coloplast Corp. | 2006-10-13 | 423 | 0 |
| K033869 | CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 I | Coloplast Corp. | 2004-05-17 | 157 | 0 |
| K022416 | CONTREET FOAM ADHESIVE/NON-ADHESIVE | Coloplast Corp. | 2003-02-03 | 194 | 0 |
| K023254 | SPEEDICATH | Coloplast Corp. | 2003-01-27 | 119 | 0 |
| K013525 | CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 | Coloplast Corp. | 2002-10-04 | 346 | 0 |
| K991202 | MODIFICATION TO WOUN'DRES | Coloplast Corp. | 1999-06-04 | 74 | 0 |
| K982493 | COMPEED PSORIASIS DRESSING | Coloplast Corp. | 1999-01-28 | 195 | 0 |
| K983519 | COMFEEL SEASORB DRESSING | Coloplast Corp. | 1998-12-30 | 83 | 1 |
| K983163 | BIATAIN FOAM DRESSING | Coloplast Corp. | 1998-12-16 | 97 | 0 |
| K983173 | BIATAIN FOAM ADHESIVE DRESSING | Coloplast Corp. | 1998-12-16 | 97 | 0 |
| K983042 | SWEEN WOUN'DRES | Coloplast Corp. | 1998-11-25 | 86 | 0 |
| K973070 | CONVEEN EASICATH SET | Coloplast Corp. | 1997-11-06 | 80 | 0 |
| K971597 | COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) | Coloplast Corp. | 1997-07-29 | 89 | 0 |
| K955609 | CONVEEN URINE BAG - STERILE | Coloplast Corp. | 1995-12-29 | 21 | 0 |
| K954857 | COMFEEL:ALGINATE FILLER | Coloplast Corp. | 1995-11-14 | 22 | 0 |
| K953783 | CONVEEN LEG BAG STRAP | Coloplast Corp. | 1995-09-13 | 30 | 0 |
| K923351 | SKIN SUPPORT PREP PAD | Coloplast Corp. | 1992-09-14 | 68 | 0 |
| K921535 | SUOENA AFFINITY (TM) MODEL #802 | Coloplast Corp. | 1992-05-11 | 41 | 0 |
| K915382 | AMOENA AFFINITY MODEL #802 | Coloplast Corp. | 1992-01-14 | 46 | 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