510(k) Report

FDA applicant

Coloplast A/S

Plymouth, MN71 decisions1983–20232 recalls

FDA records 71 decisions for Coloplast A/S (Plymouth, MN) from 1983 to 2023: 71 510(k) clearances. Most are in product codes EXB (Collector, Ostomy) and FRO (Dressing, Wound, Drug). Its devices cite 48 predicates, 19 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Coloplast A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2009: 42010: 42011: 32012: 82013: 32014: 22015: 42018: 22020: 12022: 12023: 1
2007high 8 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2013

2012: 12013: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Coloplast A/S by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Coloplast A/S’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • EXBCollector, Ostomy11decisions
  • FRODressing, Wound, Drug6decisions
  • KMFBandage, Liquid5decisions
  • KNXCollector, Urine, (And Accessories) For Indwelling Catheter5decisions
  • KNTTubes, Gastrointestinal (And Accessories)4decisions
  • OTMMesh, Surgical, For Stress Urinary Incontinence, Male4decisions

Also: FED (4), OTO (3), GBM (3), OCY (2), EXJ (2), EXD (2).

Whose devices does it build on?

Its devices cite 48 predicates; 19 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 43 times; 19 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K100218Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMColoplast A/S · 20105cite it
  • K112322Restorelle Polypropylene Y MeshColoplast A/S · 20123cite it
  • K121458Speedicath Compact Set (12/18 FR)Coloplast A/S · 20122cite it
  • K083770Coloplast Peristeen Anal Irrigation (Pai) SystemColoplast A/S · 20092cite it
  • K140310Peristeen Anal Irrigation SystemColoplast A/S · 20152cite it
  • K102485RE-Trace Ureteral Access SheathColoplast A/S · 20102cite it

What has FDA decided for it lately?

  • K221874Altis Single Incision Sling SystemColoplast A/S · 2023
  • K220420Saffron Fixation SystemColoplast A/S · 2022
  • K191536Biatain Silicone AgColoplast A/S · 2020
  • K181811ReTrace Ureteral Access SheathColoplast A/S · 2018
  • K173527Digitex Delivery DeviceColoplast A/S · 2018
  • K140310Peristeen Anal Irrigation SystemColoplast A/S · 2015
  • K150935SpeediCath Compact EveColoplast A/S · 2015
  • K150927Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra…Coloplast A/S · 2015

All 71 as Coloplast A/S →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K120284Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product…May 13, 2013Class II
  • K041632Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number 501460…Mar 2, 2012

Other applicant names beginning “Coloplast”

FDA records each applicant name separately; these may or may not be the same firm.

Coloplast Corp. 73Coloplast Manufacturing Us, LLC 4