510(k) · Cleared
ClearedSilvermed Antimicrobial Silver Hydrogel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Argentis Biomedical Incorporated · FRO Dressing, Wound, Drug
Cleared on Sep 16, 2008 as substantially equivalent to K932291 (Swiss American Products, Inc., 1994) and 4 other predicates after a 327-day review. Its family tree reaches back 5 generations to 1997. 1 later device descends from it.
- Decided
- Sep 16, 2008
- Review
- 327 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K973688 (1997). 18 ancestors in all, the oldest K894541 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK973688 Duoderm Control Gel Formula Border DressingConvatec, Ltd. · 1997
- 4 generations backK983362 NU-Gel * Wound DressingJohnson & Johnson Medical, Inc. · 1998
- 3 generations backK022995 Collatek HydrogelBiocore Medical Technologies, Inc. · 2002
- 2 generations backK040019 SilversealNoble Fiber Technologies · 2004
- 1 generation backK061227 Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp. · 2006
- This deviceK073019 Silvermed Antimicrobial Silver HydrogelArgentis Biomedical Incorporated · 2008
- Descendant · cites it directly · 0 of its ownK132891 Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp. · 2014
Most influential descendants
Showing 1 of 1 · See all- K132891Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K973688 | Duoderm Control Gel Formula Border Dressing | Convatec, Ltd. | 1997 | — |
| −4 | K983362 | NU-Gel * Wound Dressing | Johnson & Johnson Medical, Inc. | 1998 | — |
| −3 | K022995 | Collatek Hydrogel | Biocore Medical Technologies, Inc. | 2002 | — |
| −2 | K040019 | Silverseal | Noble Fiber Technologies | 2004 | — |
| −1 | K061227 | Hydrolyzed Collagen/AG Wound Gel with Silver | The Hymed Group Corp. | 2006 | — |
| 0 (this device) | K073019 | Silvermed Antimicrobial Silver Hydrogel | Argentis Biomedical Incorporated | 2008 | — |
| +1 | K132891 | Hydrolyzed Collagen/AG Wound Gel with Silver | The Hymed Group Corp. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (5)
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 |
|---|---|---|---|
| * | K932291 | Eutra Gel for Wound DressingSummary page 1…timicrobial Silver Hydrogel is substantially equivalent to the following hydrogels: * Eutra Gel For Wound Dressing K932291 * SilvaSorb Silver Antimicrobial Wound Gel or AcryDerm Silver Antimicrobial Wound Dressing… | 1994 |
| * | K011994 | Acryderm Silver Anttimicrobial Wound Gel Model# a-002101 | 2001 |
| * | K062212 | Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-SSummary page 1…Dressing KOJ1 1994 * Silver Shield T m Antimicrobial Skin and Wound Gel K062212 * Hydrolyzed Collagen Gel with Silver K06 1227 * Etta Silver Antimicrobial… | 2006 |
| * | K061227 | Hydrolyzed Collagen/AG Wound Gel with SilverSummary page 1…kin and Wound Gel K062212 * Hydrolyzed Collagen Gel with Silver K06 1227 * Etta Silver Antimicrobial Wound Gel K071703… | 2006 |
| * | K071703 | Elta Silver Antimicrobial Wound Gel Dressing, Wound and Burn, Hydrogel W/Drug and/or…Summary page 1…062212 * Hydrolyzed Collagen Gel with Silver K06 1227 * Etta Silver Antimicrobial Wound Gel K071703 2-1 KO 73 019 SilverMed Antimicrob… | 2007 |
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 |
|---|---|---|---|
| K132891 | Hydrolyzed Collagen/AG Wound Gel with Silver | 2014 | 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 11 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K132891 (The Hymed Group Corp., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K932291.
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?
SilverMedTM Antimicrobial Hydrogel is indicated for the management of minor burns, superficial cuts, lacerations, abrasions and minor irritation of the skin. Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073019 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073019: Silvermed Antimicrobial Silver Hydrogel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073019
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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