510(k) · Cleared
ClearedLUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huizhou Foryou Medical Devices Co., Ltd. · FRO Dressing, Wound, Drug
Cleared on Apr 22, 2022 as substantially equivalent to K083103 (Acrymed, Inc., 2009) after a 372-day review. Its family tree reaches back 1 generation to 2009. 1 later device descends from it.
- Decided
- Apr 22, 2022
- Review
- 372 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K083103 (2009). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK083103 Acryderm Antimicrobial Silver Gel Wound Dressing Model #BAcrymed, Inc. · 2009
- This deviceK211123 LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound GelHuizhou Foryou Medical Devices Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK251929 SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K083103 | Acryderm Antimicrobial Silver Gel Wound Dressing Model #B | Acrymed, Inc. | 2009 | — |
| 0 (this device) | K211123 | LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel | Huizhou Foryou Medical Devices Co., Ltd. | 2022 | — |
| +1 | K251929 | SilverCeuticals® Antimicrobial Wound Gel | Silverceuticals, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K083103 | Acryderm Antimicrobial Silver Gel Wound Dressing Model #BSummary page 4…or Usual Name: Silver Wound Gel Classification Name: Dressing, Wound, Drug Regulatory Class: Unclassified Product Code: FRO 3. PREDICATE DEVICE: 510(k) Number: K083103 K211123… | 2009 |
| † | K140483 | Asap Otc Wound Dressing Gel | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251929 | SilverCeuticals® Antimicrobial Wound Gel | 2026 | 0 |
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 FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Prescription:
LUOFUCON® Silver Wound Gel is under the medical supervision of a healthcare professional for the management of 1st and 2nd 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.
OTC:
LUOFUCON® Silver Antimicrobial Wound Gel is indicated for the topical management of minor abrasions, minor cuts, minor lacerations and minor burns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211123 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211123: LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211123
Report an extraction error
Are you the manufacturer?
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