510(k) · Cleared
ClearedAcryderm Silver Anttimicrobial Wound Gel Model# a-002101
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acrymed, Inc. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Nov 8, 2001 after a 135-day review. The FDA summary names its predicate without a number. 118 later devices descend from it.
- Decided
- Nov 8, 2001
- Review
- 135 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 0
118 later devices descend from it, 12 citing it directly.
- This deviceK011994 Acryderm Silver Anttimicrobial Wound Gel Model# a-002101Acrymed, Inc. · 2001
- Descendant · cites it directly · 97 of its ownK040019 SilversealNoble Fiber Technologies · 2004
- Descendant · cites it directly · 85 of its ownK062212 Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-SAnacapa Technologies, Inc. · 2006
- Descendant · cites it directly · 73 of its ownK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- Descendant · 2 generations on · 66 of its ownK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
- Descendant · 3 generations on · 37 of its ownK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
Showing 5 of 118 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 118 · See all- K040019SilversealNoble Fiber Technologies · 2004 · cites it directly97descendants
- K062212Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-SAnacapa Technologies, Inc. · 2006 · cites it directly85descendants
- K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007 · cites it directly73descendants
- K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc. · 2008 · 2 generations on66descendants
- K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · 3 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011994 | Acryderm Silver Anttimicrobial Wound Gel Model# a-002101 | Acrymed, Inc. | 2001 | — |
| +1 | K040019 | Silverseal | Noble Fiber Technologies | 2004 | — |
| +1 | K062212 | Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-S | Anacapa Technologies, Inc. | 2006 | — |
| +1 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| +2 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
| +3 | K090206 | Oculus Puracyn Antimicrobial Skin and Wound Cleanser | Oculus Innovative Sciences, Inc. | 2009 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 9 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 9 | 0 |
| 2015 | 7 | 0 |
| 2016 | 6 | 0 |
| 2017 | 9 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 6 | 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 |
|---|---|---|---|
| * | — | AcryDerm Silver Antimicrobial Wound Dressing Named without a submission number | |
| * | — | AcryDerm Gel Wound Dressing Named without a submission number |
What descends from it? (118)
See all 11812 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040019 | Silverseal | 2004 | 97 |
| K062212 | Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-S | 2006 | 85 |
| K063069 | Silvaklenz Skin and Wound Clenser Solution | 2007 | 73 |
| K061227 | Hydrolyzed Collagen/AG Wound Gel with Silver | 2006 | 21 |
| K063063 | Silvacide Skin & Wound Moisturizing Solution | 2007 | 14 |
| K070333 | Acryderm Silver Antimicrobial Otc Wound Gel | 2007 | 10 |
| K082333 | Asap Wound Dressing Gel | 2009 | 6 |
| K073197 | Silver Antimicrobial Wound Gel | 2008 | 2 |
| K132326 | Ionsil Gel | 2014 | 1 |
| K073019 | Silvermed Antimicrobial Silver Hydrogel | 2008 | 1 |
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?
- Of its descendants, K040019 (Noble Fiber Technologies, 2004) has gone furthest, with 97 descendants of its own.
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?
AcryDerm Silver Antimicrobial Wound Gel is an amorphous wound moisture management gel that is an effective antimicrobial barrier. The antimicrobial barrier function of the dressing may help control bioburden and reduce the incidence of infection in partial and full thickness wounds including decubitus ulcers; venous stasis ulcers, diabetic ulcers, first and second degree bumns, abrasions and lacerations, donor sites and surgical wounds. AcryDerm Silver may be used over debrided and grafted partial thickness wounds.
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/K011994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011994: Acryderm Silver Anttimicrobial Wound Gel Model# a-002101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011994
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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