510(k) · Cleared
ClearedAcryderm Antimicrobial Silver Gel Wound Dressing Model #B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acrymed, Inc. · FRO Dressing, Wound, Drug
Cleared on Feb 26, 2009 after a 129-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Feb 26, 2009
- Review
- 129 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 5 citing it directly.
- This deviceK083103 Acryderm Antimicrobial Silver Gel Wound Dressing Model #BAcrymed, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK092826 Asap Antimicrobial Silver Wound Dressing GelAmerican Biotech Labs · 2009
- Descendant · cites it directly · 1 of its ownK211123 LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound GelHuizhou Foryou Medical Devices Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK251929 SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK250115 Hemastyl (™) Wound DressingRapid Nexus Nanotech Wound Solutions, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK212521 Field Shield Wound DressingKericure, Inc. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K092826Asap Antimicrobial Silver Wound Dressing GelAmerican Biotech Labs · 2009 · cites it directly2descendants
- K211123LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound GelHuizhou Foryou Medical Devices Co., Ltd. · 2022 · cites it directly1descendant
- K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc. · 2026 · 2 generations on0descendants
- K250115Hemastyl (™) Wound DressingRapid Nexus Nanotech Wound Solutions, Inc. · 2025 · cites it directly0descendants
- K212521Field Shield Wound DressingKericure, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083103 | Acryderm Antimicrobial Silver Gel Wound Dressing Model #B | Acrymed, Inc. | 2009 | — |
| +1 | K092826 | Asap Antimicrobial Silver Wound Dressing Gel | American Biotech Labs | 2009 | — |
| +1 | K211123 | LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel | Huizhou Foryou Medical Devices Co., Ltd. | 2022 | — |
| +2 | K251929 | SilverCeuticals® Antimicrobial Wound Gel | Silverceuticals, Inc. | 2026 | — |
| +1 | K250115 | Hemastyl (™) Wound Dressing | Rapid Nexus Nanotech Wound Solutions, Inc. | 2025 | — |
| +1 | K212521 | Field Shield Wound Dressing | Kericure, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 FRO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRO device
- #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 Gel Named without a submission number | |
| * | — | AcryDerm Silver Antimicrobial OTC Wound Gel Named without a submission number |
What descends from it? (7)
5 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?
- Of its descendants, K092826 (American Biotech Labs, 2009) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, 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 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
Under the supervision of a healthcare professional, AcryDerm Silver Antimicrobial Wound Gel Model #B is indicated for the management of 1s and 2d degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.
Over the Counter Use: OTC: AcryDerm Wound Gel Model #B is indicated for the management of minor abrasions, cuts, lacerations and scalds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083103: Acryderm Antimicrobial Silver Gel Wound Dressing Model #B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083103
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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