510(k) · Cleared
Cleared3M Tegaderm Silver (AG) Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · FRO Dressing, Wound, Drug
Cleared on Dec 16, 2005 as substantially equivalent to K040890 (3M Company, 2004) and 1 other predicate after a 24-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.
- Decided
- Dec 16, 2005
- Review
- 24 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K914579 (1992). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 1 generation backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- This deviceK053256 3M Tegaderm Silver (AG) Mesh3M Company · 2005
- Descendant · cites it directly · 0 of its ownK152544 Agem Ag Mesh Dressing with SilverShenzhen Yuanxing Nano-Pharma Co., Ltd. · 2016
Most influential descendants
Showing 1 of 1 · See all- K152544Agem Ag Mesh Dressing with SilverShenzhen Yuanxing Nano-Pharma Co., Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −1 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| 0 (this device) | K053256 | 3M Tegaderm Silver (AG) Mesh | 3M Company | 2005 | — |
| +1 | K152544 | Agem Ag Mesh Dressing with Silver | Shenzhen Yuanxing Nano-Pharma Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K040890 | 3M Tegaderm SilverSummary page 1…cation Name: Unclassified * Predicate Device: 3 MTm TegaderMTM Silver Nonwoven Dressing has predicates 3 MTM TegaderMTM Silver Nonwoven Dressing (K040890) and ActicoatTM Silver Coated Dressing, aka Acticoatm Burn Antimicrobial Dressing, manufactured by Smith & Nephew (orig… | 2004 |
| * | K955453 | Acticoat Silver Coated DressingSummary page 1…n Dressing (K040890) and ActicoatTM Silver Coated Dressing, aka Acticoatm Burn Antimicrobial Dressing, manufactured by Smith & Nephew (originally cleared under K955453). *Description of Device: 3Mm TegaderM TM Silver Nonwoven Dressing is a nonwoven dressing that contains (8 mg/gm… | 1996 |
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 |
|---|---|---|---|
| K152544 | Agem Ag Mesh Dressing with Silver | 2016 | 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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K152544 (Shenzhen Yuanxing Nano-Pharma Co., Ltd., 2016) has gone furthest, with 0 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.
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?
3M Tegaderm Silver Nonwoven Dressing is indicated for use as a primary dressing over:
- abrasions
- ulcers
- trauma wounds
- surgical wounds
- first and second degree burns
- donor sites
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053256 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053256: 3M Tegaderm Silver (AG) Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053256
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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