510(k) · Cleared
ClearedContreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast Corp. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Oct 4, 2002 as substantially equivalent to K001519 (Westaim Biomedical, Inc., 2000) and 2 other predicates after a 346-day review. Its family tree reaches back 2 generations to 1997. 13 later devices descend from it.
- Decided
- Oct 4, 2002
- Review
- 346 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K970566 (1997). 5 ancestors in all, the oldest K941263 (1994). 13 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK970566 Arglaes Film DressingMaersk Medical, Ltd. · 1997
- 1 generation backK990810 Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingMaersk Medical, Ltd. · 1999
- This deviceK013525 Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4…Coloplast Corp. · 2002
- Descendant · cites it directly · 7 of its ownK061220 Urgotul AGLaboratoires Urgo · 2006
- Descendant · 2 generations on · 6 of its ownK062559 Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2007
- Descendant · 2 generations on · 2 of its ownK100430 Urgotul AG, Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2010
- Descendant · cites it directly · 2 of its ownK050032 Euromed Sureskin Iii with Silver Wound DressingsEuromed, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK033900 X-Static Silverseal Hydrocolloid Film and Island DressingNoble Fiber Technologies · 2005
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K061220Urgotul AGLaboratoires Urgo · 2006 · cites it directly7descendants
- K062559Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2007 · 2 generations on6descendants
- K100430Urgotul AG, Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2010 · 2 generations on2descendants
- K050032Euromed Sureskin Iii with Silver Wound DressingsEuromed, Inc. · 2006 · cites it directly2descendants
- K033900X-Static Silverseal Hydrocolloid Film and Island DressingNoble Fiber Technologies · 2005 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970566 | Arglaes Film Dressing | Maersk Medical, Ltd. | 1997 | — |
| −1 | K990810 | Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing | Maersk Medical, Ltd. | 1999 | — |
| 0 (this device) | K013525 | Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X… | Coloplast Corp. | 2002 | — |
| +1 | K061220 | Urgotul AG | Laboratoires Urgo | 2006 | — |
| +2 | K062559 | Urgocell AG Antimicrobial Wound Dressing with Silver | Laboratoires Urgo | 2007 | — |
| +2 | K100430 | Urgotul AG, Antimicrobial Wound Dressing with Silver | Laboratoires Urgo | 2010 | — |
| +1 | K050032 | Euromed Sureskin Iii with Silver Wound Dressings | Euromed, Inc. | 2006 | — |
| +1 | K033900 | X-Static Silverseal Hydrocolloid Film and Island Dressing | Noble Fiber Technologies | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MGQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K001519 | Acticoat 7 Dressing | 2000 |
| * | K990810 | Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingSummary page 1…R878.4020) Legally marketed device to which substantial wuivalence is claimed Acticoat 7 Dressing (KO01519) ARGLAES-AB Antimicrobial Barrier Film and Island Dressings (K990810) Comfeel Plus Ulcer Dressing (K941263) Description of the device Contreet Hydrocolloid Dressing is an antibacterial hydrocolloi… | 1999 |
| * | K941263 | Comfeel Plus Wound DressingSummary page 1…which substantial wuivalence is claimed Acticoat 7 Dressing (KO01519) ARGLAES-AB Antimicrobial Barrier Film and Island Dressings (K990810) Comfeel Plus Ulcer Dressing (K941263) Description of the device Contreet Hydrocolloid Dressing is an antibacterial hydrocolloid dressing with silver providing an op… | 1994 |
What descends from it? (13)
See all 134 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K061220 (Laboratoires Urgo, 2006) has gone furthest, with 7 descendants of its own.
- 8 other devices also cite its predicate K001519.
How does its category compare?
All MGQ devicesMGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MGQ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MGQ
Too few MGQ 510(k)s in any year since 2007 to give a median.
Recalls per year · MGQ
4in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGQ
5in 2025
MAUDE reports naming product code MGQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 4 | 10 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Contreet Hydrocolloid Dressing is indicated for use in the management of low to highly exudating leg ulcers, skin tears and pressure sores. The dressing can also be used for 2"6degree burns, 2"ddegree partial thickness bums, donor sites, post operative wounds and skin abrasions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013525: Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013525
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026