510(k) · Cleared
ClearedModification to Woun'dres
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 Jun 4, 1999 as substantially equivalent to K894541 (Carrington Laboratories, Inc., 1989) and 1 other predicate after a 74-day review. Its family tree reaches back 1 generation to 1989. 112 later devices descend from it.
- Decided
- Jun 4, 1999
- Review
- 74 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K894541 (1989). 2 ancestors in all. 112 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK894541 Carrington Dermal Wound GelCarrington Laboratories, Inc. · 1989
- This deviceK991202 Modification to Woun'dresColoplast Corp. · 1999
- Descendant · cites it directly · 106 of its ownK022995 Collatek HydrogelBiocore Medical Technologies, Inc. · 2002
- Descendant · cites it directly · 97 of its ownK040019 SilversealNoble Fiber Technologies · 2004
- Descendant · 2 generations on · 73 of its ownK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- Descendant · 3 generations on · 66 of its ownK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- Descendant · 4 generations on · 37 of its ownK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
Showing 5 of 112 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 112 · See all- K022995Collatek HydrogelBiocore Medical Technologies, Inc. · 2002 · cites it directly106descendants
- K040019SilversealNoble Fiber Technologies · 2004 · cites it directly97descendants
- K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007 · 2 generations on73descendants
- K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc. · 2008 · 3 generations on66descendants
- K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · 4 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894541 | Carrington Dermal Wound Gel | Carrington Laboratories, Inc. | 1989 | — |
| 0 (this device) | K991202 | Modification to Woun'dres | Coloplast Corp. | 1999 | — |
| +1 | K022995 | Collatek Hydrogel | Biocore Medical Technologies, Inc. | 2002 | — |
| +1 | K040019 | Silverseal | Noble Fiber Technologies | 2004 | — |
| +2 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| +3 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| +4 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 7 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 5 | 0 |
| 2017 | 9 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 0 |
| 2022 | 7 | 0 |
| 2023 | 7 | 0 |
| 2024 | 8 | 0 |
| 2025 | 5 | 0 |
| 2026 | 13 | 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? (2)
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 |
|---|---|---|---|
| * | K894541 | Carrington Dermal Wound GelSummary page 1…SU (80) STATEMENT OF SUBSTANTIAL EQUIVALENCE Woun'Dres® is substantially equivalent to Carrasyn Hydrogel Wound Dressing which obtained marketing approvai under 510(k) K894541 and DuoDerm Hydroactive Gel which obtained marketing approval under 510(k) K925993. Carrasyn Hydrogel Wound Dressing was found to… | 1989 |
| * | K925993 | Duoderm Hydroactive DressingSummary page 1…ent to Carrasyn Hydrogel Wound Dressing which obtained marketing approvai under 510(k) K894541 and DuoDerm Hydroactive Gel which obtained marketing approval under 510(k) K925993. Carrasyn Hydrogel Wound Dressing was found to be substantially equivalent to devices marketed in interstate commerce prior to Ma… | 1993 |
What descends from it? (112)
See all 1126 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?
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?
May be used for superficial wounds and abrasions and minor burns. Use under the supervision of health care professionals for the local management of partial- and full-thickness wounds including pressure, and diabetic ulcers; lower extremity ulcers including those of venous, arterial and mixed etiology; surgical wounds; first- and second-degree burns including management of abrasions and burns associated with dermabrasion and laser resurfacing.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991202 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991202: Modification to Woun'dres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991202
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026