510(k) · Cleared
ClearedSilverCeuticals® Antimicrobial Wound Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Silverceuticals, Inc. · FRO Dressing, Wound, Drug
Cleared on Jun 24, 2026 as substantially equivalent to K211123 (Huizhou Foryou Medical Devices Co., Ltd., 2022) after a 366-day review. Its family tree reaches back 2 generations to 2009.
- Decided
- Jun 24, 2026
- Review
- 366 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K083103 (2009). No later device cites it as a predicate yet.
- Root · 2 generations backK083103 Acryderm Antimicrobial Silver Gel Wound Dressing Model #BAcrymed, Inc. · 2009
- 1 generation backK211123 LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound GelHuizhou Foryou Medical Devices Co., Ltd. · 2022
- This deviceK251929 SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K083103 | Acryderm Antimicrobial Silver Gel Wound Dressing Model #B | Acrymed, Inc. | 2009 | — |
| −1 | K211123 | LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel | Huizhou Foryou Medical Devices Co., Ltd. | 2022 | — |
| 0 (this device) | K251929 | SilverCeuticals® Antimicrobial Wound Gel | Silverceuticals, Inc. | 2026 | — |
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? (1)
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 |
|---|---|---|---|
| * | K211123 | LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound GelSummary page 5…Name: Silver Wound Gel Classification Name: Wound Dressing Regulatory Class: Unclassified Product Code: FRO 3. PREDICATE / REFERENCE DEVICES 1) 510(k) number: K211123 (Predicate Device) • Product Name: LUOFUCON Silver Wound Gel • Manufacturer: Huizhou Foryou Medical Devices Co.,… | 2022 |
| † | K140483 | Asap Otc Wound Dressing Gel | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
The device is indicated for the OTC local management of: minor burns, minor lacerations, minor abrasions, minor cuts,
It is prescription indicated by healthcare practitioner for the management of: wounds such as 1st and partial-thickness 2nd degree burns, stasis ulcers, pressure ulcers, diabetic ulcers, device insertion site wounds, surgical incision sites, graft sites, donor sites, and skin tears.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251929 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251929: SilverCeuticals® Antimicrobial Wound Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251929
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026