510(k) Report

510(k) · Cleared

Cleared

Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-S

K062212510(k) TraditionalCleared Nov 21, 2006112-day reviewClass U

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

Anacapa Technologies, Inc. · FRO Dressing, Wound, Drug

Cleared on Nov 21, 2006 as substantially equivalent to K011994 (Acrymed, Inc., 2001) after a 112-day review. Its family tree reaches back 1 generation to 2001. 85 later devices descend from it.

Decided
Nov 21, 2006
Review
112 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K011994 (2001). 85 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2010: 5 descendants cleared2008: 3 descendants cleared2016: 4 descendants cleared2009: 7 descendants cleared2013: 3 descendants cleared2007: 1 descendant cleared2014: 7 descendants cleared2011: 3 descendants cleared2015: 6 descendants cleared2012: 2 descendants cleared2017: 6 descendants cleared2023: 4 descendants cleared2020: 3 descendants cleared2024: 5 descendants cleared2018: 4 descendants cleared2019: 2 descendants cleared2025: 4 descendants cleared2026: 11 descendants cleared2021: 1 descendant cleared2022: 4 descendants clearedK011994 · Acryderm Silver Anttimicrobial Wound Gel Model# a-002101 · Acrymed, Inc. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 8 descendants2 generations forward: 25 descendants3 generations forward: 27 descendants4 generations forward: 16 descendants5 generations forward: 6 descendants6 generations forward: 3 descendants K011994 · Acryderm Silver Anttimicrobial Wound Gel Model# a-002101 · Acrymed, Inc. · 20010+5
  1. Root · 1 generation backK011994 Acryderm Silver Anttimicrobial Wound Gel Model# a-002101Acrymed, Inc. · 2001
  2. This deviceK062212 Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-SAnacapa Technologies, Inc. · 2006
  3. Descendant · cites it directly · 66 of its ownK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
  4. Descendant · 2 generations on · 37 of its ownK090206 Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · Recalled
  5. Descendant · 2 generations on · 31 of its ownK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
  6. Descendant · 3 generations on · 25 of its ownK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
  7. Descendant · 2 generations on · 21 of its ownK101882 Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010

Showing 5 of 85 descendants. See all descendants

Descendants cleared per year

2007: 12008: 32009: 72010: 52011: 32012: 22013: 32014: 72015: 62016: 42017: 62018: 42019: 22020: 32021: 12022: 42023: 42024: 52025: 42026: 11
2007high 11 (2026) · low 1 (2007)2026

Most influential descendants

Showing 5 of 85 · See all
  • K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc. · 2008 · cites it directly66descendants
  • K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. · 2009 · 2 generations on37descendants
  • K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010 · 2 generations on31descendants
  • K123072Vashe Wound Therapy SolutionPuricore, Inc. · 2013 · 3 generations on25descendants
  • K101882Prontosan Antimicrobial Wound GelB.Braun Medical, Inc. · 2010 · 2 generations on21descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011994Acryderm Silver Anttimicrobial Wound Gel Model# a-002101Acrymed, Inc.2001—
0 (this device)K062212Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-SAnacapa Technologies, Inc.2006—
+1K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and…Anacapa Technologies, Inc.2008—
+2K090206Oculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc.20093
+2K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc.2010—
+3K123072Vashe Wound Therapy SolutionPuricore, Inc.2013—
+2K101882Prontosan Antimicrobial Wound GelB.Braun Medical, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200830
200970
201050
201130
201220
201330
201470
201560
201640
201760
201840
201920
202030
202110
202240
202340
202450
202540
2026110
FIG. 1 — Lineage of K062212, 2001–2026Source: 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 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. #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? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K011994Acryderm Silver Anttimicrobial Wound Gel Model# a-002101
Summary page 1
…s for substantial equivalence comparison: Silver Shield Antimicrobial Skin and Wound Gel is substantially equivalent to AcryDerm Silver Antimicrobial Wound Gel, 510(K) # K011994. (AcryMed, Inc., OR also distributed under the trade name SilvaSorbTM Gel, Silver Antimicrobial Wound Gel (Medline Industries, In…
Acrymed, Inc.2001—

Also cleared against K011994: 11 other devices →

What descends from it? (85)

See all 85

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

NumberDeviceApplicantDecidedDescendants
K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc.200866
K082333Asap Wound Dressing GelAmerican Biotech Labs20096
K130857Prontosan Wound Gel XB.Braun Medical, Inc.20133
K073197Silver Antimicrobial Wound GelAdvanced Medical Solutions Limited20082
K073019Silvermed Antimicrobial Silver HydrogelArgentis Biomedical Incorporated20081
K072378Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625…Arthrex, Inc.20071
K152519MTR550 (Tentative) Antimicrobial Silver Wound GelMedical Technology Research, Inc.20160
K090345Mendasil TWG Gel Antimicrobial Skin and Wound GelConseal International, Inc.20100

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?

  • Its one ancestor has no recall.
  • Of its descendants, K073547 (Anacapa Technologies, Inc., 2008) has gone furthest, with 66 descendants of its own.
  • 11 other devices also cite its predicate K011994.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

Silver ShieldTM Antimicrobial Skin and Wound Gel is intended for OTC use for Abrasions and lacerations and under the supervision of a health care professional in the management of Stage 1-1V Pressure Ulcers, Partial and Full thickness Wounds, Diabetic Foot and Leg Ulcers, Grafted and donor sites,

Indications for use as stated in the FDA summary.

Also cleared against K011994

11 other devices cite the same predicate.

  • K132326Ionsil GelVirchow Biotech Pvt, Ltd. · 2014
  • K090345Mendasil TWG Gel Antimicrobial Skin and Wound GelConseal International, Inc. · 2010
  • K082333Asap Wound Dressing GelAmerican Biotech Labs · 2009
  • K073019Silvermed Antimicrobial Silver HydrogelArgentis Biomedical Incorporated · 2008
  • K073197Silver Antimicrobial Wound GelAdvanced Medical Solutions Limited · 2008
  • K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007

More from Anacapa Technologies, Inc.

2 FDA decisions under this applicant name. See the company

  • K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc. · 2008

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/K062212 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062212: Silver Shield Antimicrobial Skin and Wound Gel, Model 3015-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062212

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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