# Coloplast Corp.

- Location (FDA's records): Plymouth, MN
- FDA decisions: 73 (1972–2026): 70 510(k) clearances and 3 original PMA approvals
- Names in FDA's records: Coloplast Corp. (57); Coloplast (15); Coloplast A.S. (1)
- Product codes: EZD (13), GBM (10), FAD (7), FRO (6), KCZ (3), GBI (3), OTO (3), MGQ (3), EZN (2), LJE (2), KMF (2), FAQ (2)
- 510(k) review time since 2016: median 190 days, against 147 for FDA's reviews in the same codes and years (15 of 29 faster)
- Predicates its devices cite: 81 (29 its own); citations of its devices by later devices: 62 (29 its own)
- Recalls linked to its devices: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Coloplast A/S: 10 (https://510kreport.com/company/coloplast-a-s)
- Porges Corp.: 5 (https://510kreport.com/company/porges)
- Bivona Medical Technologies: 3 (https://510kreport.com/company/bivona-medical-technologies)
- International Regulatory Consultants: 3 (https://510kreport.com/company/international-regulatory-consultants)
- Convatec, A Division of E.R. Squibb & Sons: 3 (https://510kreport.com/company/convatec-a-division-of-er-squibb-sons)
- Cook Urological, Inc.: 2 (https://510kreport.com/company/cook-urological)
- Westaim Biomedical, Inc.: 2 (https://510kreport.com/company/westaim-biomedical)
- C.R. Bard, Inc.: 2 (https://510kreport.com/company/cr-bard)

## Firms that cite its devices most
- Coloplast A/S: 4 (https://510kreport.com/company/coloplast-a-s)
- Noble Fiber Technologies, Inc.: 2 (https://510kreport.com/company/noble-fiber-technologies)
- Well Lead Medical Co., Ltd.: 2 (https://510kreport.com/company/well-lead-medical)
- Coreleader Biotech Co., Ltd.: 2 (https://510kreport.com/company/coreleader-biotech)
- Laboratoires Urgo: 2 (https://510kreport.com/company/laboratoires-urgo)
- Oasis Medikal Urunler Kimya Sanayi VE Tic A.S.: 2 (https://510kreport.com/company/oasis-medikal-urunler-kimya-sanayi-ve-tic)
- 3-D Matrix, Inc.: 2 (https://510kreport.com/company/3-d-matrix)
- B.Braun Medical, Inc.: 2 (https://510kreport.com/company/b-braun-medical)

## Its most-cited devices
- K022416: Contreet Foam Adhesive/Non-Adhesive (2003), cited by 7
- K023254: Speedicath (2003), cited by 7
- K991202: Modification to Woun'dres (1999), cited by 6
- K072808: Speedicath Compact (2007), cited by 5
- K013525: Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) (2002), cited by 4
- K190620: SpeediCath Flex Coude Pro (2019), cited by 3

## Recent decisions
- K262045: Luja Soft (Jul 7, 2026)
- K252140: Heylo™ System (Oct 6, 2025)
- K251116: Luja Coudé (Jun 27, 2025)
- K250270: Luja Set (Apr 17, 2025)
- K242049: SureCath Set (Nov 26, 2024)
- K241210: Luja Coude (Nov 21, 2024)
- K242173: Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) (Nov 12, 2024)
- K242473: Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) (Oct 18, 2024)

Source page: https://510kreport.com/company/coloplast