510(k) Report

510(k) · Cleared

Cleared

Dermagran Wound Dressing Cleaner W/Zinc

K954743510(k) TraditionalCleared Nov 2, 199517-day reviewClass U

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

Derma Sciences, Inc. · FRO Dressing, Wound, Drug

Cleared on Nov 2, 1995 after a 17-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 108 devices in its family, counting itself, has a Class I recall. 107 later devices descend from it.

Decided
Nov 2, 1995
Review
17 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
0

107 later devices descend from it, 3 citing it directly. 1 of the 108 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1997: 1 descendant cleared2002: 1 descendant cleared2009: 8 descendants cleared2004: 1 descendant cleared2006: 2 descendants cleared2007: 5 descendants cleared2005: 3 descendants cleared2020: 4 descendants cleared2008: 6 descendants cleared, 1 with a Class I recall12011: 2 descendants cleared2016: 8 descendants cleared2012: 2 descendants cleared2022: 5 descendants cleared2021: 3 descendants cleared2014: 4 descendants cleared2010: 4 descendants cleared2015: 5 descendants cleared2017: 7 descendants cleared2018: 6 descendants cleared2013: 3 descendants cleared2019: 3 descendants cleared2024: 4 descendants cleared2025: 5 descendants cleared2026: 11 descendants cleared2023: 4 descendants cleared1995200020052010201520202025
  1. This deviceK954743 Dermagran Wound Dressing Cleaner W/ZincDerma Sciences, Inc. · 1995
  2. Descendant · cites it directly · 105 of its ownK022670 Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002
  3. Descendant · 2 generations on · 89 of its ownK042729 Dermacyn Wound IrrigationOculus Innovative Sciences, Inc. · 2005
  4. Descendant · 2 generations on · 73 of its ownK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
  5. Descendant · 3 generations on · 66 of its ownK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
  6. Descendant · 2 generations on · 52 of its ownK060113 Dermacyn Wound CareOculus Innovative Sciences, Inc. · 2006

Showing 5 of 107 descendants. See all descendants

Descendants cleared per year

1997: 12002: 12004: 12005: 32006: 22007: 52008: 62009: 82010: 42011: 22012: 22013: 32014: 42015: 52016: 82017: 72018: 62019: 32020: 42021: 32022: 52023: 42024: 42025: 52026: 11
1997high 11 (2026) · low 0 (1998)2026

Class I recalls in this family

  • K083042 Wound Flush, Sterile Water & Normal Saline3 generations on · 2008

Most influential descendants

Showing 5 of 107 · See all
  • K022670Carraklenz and UltraklenzCarrington Laboratories, Inc. · 2002 · cites it directly105descendants
  • K042729Dermacyn Wound IrrigationOculus Innovative Sciences, Inc. · 2005 · 2 generations on89descendants
  • K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007 · 2 generations on73descendants
  • K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc. · 2008 · 3 generations on66descendants
  • K060113Dermacyn Wound CareOculus Innovative Sciences, Inc. · 2006 · 2 generations on52descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954743Dermagran Wound Dressing Cleaner W/ZincDerma Sciences, Inc.1995—
+1K022670Carraklenz and UltraklenzCarrington Laboratories, Inc.2002—
+2K042729Dermacyn Wound IrrigationOculus Innovative Sciences, Inc.2005—
+2K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC2007—
+3K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and…Anacapa Technologies, Inc.2008—
+2K060113Dermacyn Wound CareOculus Innovative Sciences, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200210
200410
200530
200620
200750
200861
200980
201040
201120
201220
201330
201440
201550
201680
201770
201860
201930
202040
202130
202250
202340
202440
202550
2026110
FIG. 1 — Lineage of K954743, 1995–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (107)

See all 107

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

NumberDeviceApplicantDecidedDescendants
K022670Carraklenz and UltraklenzCarrington Laboratories, Inc.2002105
K970660Dermagran Wound Management SystemDerma Sciences, Inc.199712
K080779Irrisept Wound Cleansing SystemIrrimax Corporation20099

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K083042Wound Flush, Sterile Water & Normal SalineNurse Assist, Inc. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

  • Of its descendants, K022670 (Carrington Laboratories, Inc., 2002) has gone furthest, with 105 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.

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—

More from Derma Sciences, Inc.

22 FDA decisions under this applicant name. See the company

  • K150985Medihoney Wound GelDerma Sciences, Inc. · 20151 recall
  • K133279Medihoney Wound DressingsDerma Sciences, Inc. · 2015
  • K110546Medihoney Hydrogel Sheet Dressings with Active Leptospermum HoneyDerma Sciences, Inc. · 20115 recalls
  • K101793Medihoney Gel Dressing with Active Manuka HoneyDerma Sciences, Inc. · 20114 recalls
  • K081584Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, 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/K954743 · printed Nov 5, 2026

Cite this page

510(k) Report. “K954743: Dermagran Wound Dressing Cleaner W/Zinc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954743

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026