510(k) · Cleared
ClearedSilver Antimicrobial Wound Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Medical Solutions Limited · FRO Dressing, Wound, Drug
Cleared on Aug 28, 2008 as substantially equivalent to K062212 (Anacapa Technologies, Inc., 2006) and 2 other predicates after a 289-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Aug 28, 2008
- Review
- 289 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K011994 (2001). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK011994 Acryderm Silver Anttimicrobial Wound Gel Model# a-002101Acrymed, Inc. · 2001
- 1 generation backK062212 Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-SAnacapa Technologies, Inc. · 2006
- This deviceK073197 Silver Antimicrobial Wound GelAdvanced Medical Solutions Limited · 2008
- Descendant · cites it directly · 1 of its ownK110458 Silver Antimicrobial Wound GelAdvanced Medical Solutions Limited · 2011
- Descendant · 2 generations on · 0 of its ownK152519 MTR550 (Tentative) Antimicrobial Silver Wound GelMedical Technology Research, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011994 | Acryderm Silver Anttimicrobial Wound Gel Model# a-002101 | Acrymed, Inc. | 2001 | — |
| −1 | K062212 | Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-S | Anacapa Technologies, Inc. | 2006 | — |
| 0 (this device) | K073197 | Silver Antimicrobial Wound Gel | Advanced Medical Solutions Limited | 2008 | — |
| +1 | K110458 | Silver Antimicrobial Wound Gel | Advanced Medical Solutions Limited | 2011 | — |
| +2 | K152519 | MTR550 (Tentative) Antimicrobial Silver Wound Gel | Medical Technology Research, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 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? (3)
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 |
|---|---|---|---|
| * | K062212 | Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-SSummary page 1…sified Product Code:- FRO Legally marketed device(s) for substantial equivalence comparison:- Silver ShieldTM Antimicrobial Skin and Wound Gel, 510(k) # K062212, manufactured by Anacapa Technologies, Inc., CA. AcryDerm Silver Antimicrobial Wound Gel, 510(k) # KOI 1994 and K070333, manufact… | 2006 |
| * | K011994 | Acryderm Silver Anttimicrobial Wound Gel Model# a-002101 | 2001 |
| * | K070333 | Acryderm Silver Antimicrobial Otc Wound GelSummary page 1…ieldTM Antimicrobial Skin and Wound Gel, 510(k) # K062212, manufactured by Anacapa Technologies, Inc., CA. AcryDerm Silver Antimicrobial Wound Gel, 510(k) # KOI 1994 and K070333, manufactured by AcryMed Inc., OR also distributed under the trade name SilvaSorbTM Gel, Silver Antimicrobial Wound Gel (Medline… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110458 | Silver Antimicrobial Wound Gel | 2011 | 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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K110458 (Advanced Medical Solutions Limited, 2011) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K062212.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Silver Antimicrobial Wound Gel is indicated under the medical supervision of a healthcare professional for the management of dry to moderate exuding partial to full thickness wounds, such as:
* Pressure Ulcers
* Leg Ulcers
* Diabetic Ulcers
* Graft and donor sites
* Post-operative surgical wounds
* Trauma wounds (dermal lesions, trauma injuries or incisions)
* I" and 2 nd degree bums
* Abrasions and lacerations
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073197: 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/K073197
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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