510(k) Report

510(k) · Cleared

Cleared

Elta Silver Antimicrobial Wound Gel Dressing, Wound and Burn, Hydrogel W/Drug and/or Biologic

K071703510(k) TraditionalCleared Aug 22, 200762-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Swiss American Products, Inc. · FRO Dressing, Wound, Drug

Cleared on Aug 22, 2007 after a 62-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.

Decided
Aug 22, 2007
Review
62 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
0

9 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2009: 2 descendants cleared2008: 1 descendant cleared2014: 3 descendants cleared2017: 1 descendant cleared2024: 1 descendant cleared2015: 1 descendant cleared20052010201520202025
  1. This deviceK071703 Elta Silver Antimicrobial Wound Gel Dressing, Wound and Burn…Swiss American Products, Inc. · 2007
  2. Descendant · cites it directly · 6 of its ownK082333 Asap Wound Dressing GelAmerican Biotech Labs · 2009
  3. Descendant · 2 generations on · 2 of its ownK092826 Asap Antimicrobial Silver Wound Dressing GelAmerican Biotech Labs · 2009
  4. Descendant · 2 generations on · 1 of its ownK140483 Asap Otc Wound Dressing GelAbl Medical, LLC · 2014
  5. Descendant · 2 generations on · 1 of its ownK131176 Ross RU Skin DiscontinuitiesBiotd S.A. · 2014
  6. Descendant · cites it directly · 1 of its ownK073019 Silvermed Antimicrobial Silver HydrogelArgentis Biomedical Incorporated · 2008

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2008: 12009: 22014: 32015: 12017: 12024: 1
2008high 3 (2014) · low 0 (2010)2026

Most influential descendants

Showing 5 of 9 · See all
  • K082333Asap Wound Dressing GelAmerican Biotech Labs · 2009 · cites it directly6descendants
  • K092826Asap Antimicrobial Silver Wound Dressing GelAmerican Biotech Labs · 2009 · 2 generations on2descendants
  • K140483Asap Otc Wound Dressing GelAbl Medical, LLC · 2014 · 2 generations on1descendant
  • K131176Ross RU Skin DiscontinuitiesBiotd S.A. · 2014 · 2 generations on1descendant
  • K073019Silvermed Antimicrobial Silver HydrogelArgentis Biomedical Incorporated · 2008 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K071703Elta Silver Antimicrobial Wound Gel Dressing, Wound and Burn, Hydrogel W/Drug…Swiss American Products, Inc.2007—
+1K082333Asap Wound Dressing GelAmerican Biotech Labs2009—
+2K092826Asap Antimicrobial Silver Wound Dressing GelAmerican Biotech Labs2009—
+2K140483Asap Otc Wound Dressing GelAbl Medical, LLC2014—
+2K131176Ross RU Skin DiscontinuitiesBiotd S.A.2014—
+1K073019Silvermed Antimicrobial Silver HydrogelArgentis Biomedical Incorporated2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200920
201430
201510
201710
202410
FIG. 1 — Lineage of K071703, 2007–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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. #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (9)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K082333Asap Wound Dressing GelAmerican Biotech Labs20096
K073019Silvermed Antimicrobial Silver HydrogelArgentis Biomedical Incorporated20081

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?

  • Of its descendants, K082333 (American Biotech Labs, 2009) has gone furthest, with 6 descendants of its own.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · FRO

11in 2025

2007: 292008: 262009: 312010: 312011: 272012: 242013: 192014: 222015: 282016: 282017: 232018: 202019: 162020: 122021: 82022: 92023: 182024: 242025: 112026 (partial year): 17
2007high 31 (2009) · low 8 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRO

176in 2025

2007: 187 days median2008: 130 days median2009: 136 days median2010: 146 days median2011: 177 days median2012: 96 days median2013: 194 days median2014: 214 days median2015: 249 days median2016: 222 days median2017: 147 days median2018: 206 days median2019: 270 days median2020: 226 days median2021: 275 days median2022: 332 days median2023: 283 days median2024: 263 days median2025: 176 days median2026 (partial year): 254 days median
2007high 332 (2022) · low 96 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRO

2in 2024

2007: 42008: 12009: 12011: 42013: 12014: 12015: 22016: 32017: 12019: 12021: 62022: 22023: 2, 2 Class I2024: 22026 (partial year): 2
2007high 6 (2021) · low 0 (2010)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · FRO

192in 2025

2007: 552008: 302009: 452010: 1222011: 422012: 652013: 1392014: 2692015: 2972016: 1472017: 1492018: 1282019: 1362020: 1392021: 1832022: 1762023: 1982024: 2322025: 192
2007high 297 (2015) · low 30 (2008)2025

MAUDE reports naming product code FRO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200729187455
200826130130
200931136145
2010311460122
201127177442
20122496065
2013191941139
2014222141269
2015282492297
2016282223147
2017231471149
2018202060128
2019162701136
2020122260139
202182756183
202293322176
2023182832 (2)198
2024242632232
2025111760192
2026172542—

What is it indicated for?

Elta Silver Antimicrobial Wound Gel is indicated for the management of minor bums, superficial cuts, lacerations, abrasion 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 bums, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.

Indications for use as stated in the FDA 510(k) statement.

More from Swiss American Products, Inc.

4 FDA decisions under this applicant name. See the company

  • K103713Elta Wound CleanserSwiss American Products, Inc. · 2011
  • K073610Elta Advanced Wound WashSwiss American Products, Inc. · 2008
  • K932291Eutra Gel for Wound DressingSwiss American Products, Inc. · 1994

Recent decisions in FRO

The FRO category page

  • K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH · 2026
  • K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC · 2026
  • K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026
  • K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC · 2026
  • K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc. · 2026

https://510kreport.com/device/K071703 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071703: Elta Silver Antimicrobial Wound Gel Dressing, Wound and Burn, Hydrogel W/Drug and/or Biologic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071703

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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