510(k) · Cleared
ClearedMendasil TWG Gel Antimicrobial Skin and Wound Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conseal International, Inc. · FRO Dressing, Wound, Drug
Cleared on Jan 7, 2010 as substantially equivalent to K011994 (Acrymed, Inc., 2001) and 1 other predicate after a 331-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Jan 7, 2010
- Review
- 331 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011994 (2001). No later device cites it as a predicate yet.
- 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 deviceK090345 Mendasil TWG Gel Antimicrobial Skin and Wound GelConseal International, Inc. · 2010
View 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) | K090345 | Mendasil TWG Gel Antimicrobial Skin and Wound Gel | Conseal International, Inc. | 2010 | — |
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 |
|---|---|---|---|
| * | K011994 | Acryderm Silver Anttimicrobial Wound Gel Model# a-002101 | 2001 |
| * | K062212 | Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-SSummary page 1…*: KOl1 1994 Silver Shield Antimicrobial Skin and Wound Oci (Anacapa Tech., Inc., CA) .; . K062212 "''~'arv5 20k) Description of Device; MendaSilTMl TWG Skin and Wound Gel is an amr.,… | 2006 |
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 9 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- None of the 2 ancestors has a recall.
- 11 other devices also cite its predicate K011994.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
MendaSilTM-TWG Gel Skin and Wound Gel is indicated for use under the supervision of a healthcare professional for management of partial to full thickness wounds from mild to moderate exudate such as Stage I-IV Pressure Ulcers, Partial and Full Thickness Wounds, 1st and 2nd Degree Burns, Diabetic Foot Ulcers, Venous Stasis Ulcers and surgical Incision Wounds. The Gel can also be used for management of minor cuts, scrapes/abrasions, and irritated skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090345 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090345: Mendasil TWG Gel Antimicrobial Skin and 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/K090345
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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