510(k) Report

510(k) · Cleared

Recalled · 2003

Acticoat Foam Dressing

K000051510(k) TraditionalCleared Apr 5, 200089-day reviewClass URecalls 1

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

Westaim Biomedical, Inc. · FRO Dressing, Wound, Drug

Cleared on Apr 5, 2000 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 92 later devices descend from it. It has been recalled once.

Decided
Apr 5, 2000
Review
89 days
Class
Class U
Product code
FRO
Recalls
1
Predicates
0

92 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2006: 5 descendants cleared2005: 2 descendants cleared2001: 1 descendant cleared2003: 2 descendants cleared2007: 3 descendants cleared2004: 5 descendants cleared2016: 3 descendants cleared2009: 9 descendants cleared2014: 4 descendants cleared2008: 4 descendants cleared2013: 4 descendants cleared2023: 6 descendants cleared2020: 3 descendants cleared2011: 2 descendants cleared2024: 5 descendants cleared2010: 6 descendants cleared2015: 8 descendants cleared2019: 4 descendants cleared2018: 4 descendants cleared2012: 3 descendants cleared2022: 2 descendants cleared2017: 3 descendants cleared2026: 1 descendant cleared2021: 3 descendants cleared200020052010201520202025
  1. This deviceK000051 Acticoat Foam DressingWestaim Biomedical, Inc. · 2000
  2. Descendant · cites it directly · 83 of its ownK002896 Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 2001
  3. Descendant · 2 generations on · 53 of its ownK024298 Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2003
  4. Descendant · 3 generations on · 25 of its ownK032986 Clo-Surplusp.a.D.Scion Cardio-Vascular, Inc. · 2004
  5. Descendant · 3 generations on · 17 of its ownK033869 Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004
  6. Descendant · 2 generations on · 16 of its ownK041316 Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2004

Showing 5 of 92 descendants. See all descendants

Descendants cleared per year

2001: 12003: 22004: 52005: 22006: 52007: 32008: 42009: 92010: 62011: 22012: 32013: 42014: 42015: 82016: 32017: 32018: 42019: 42020: 32021: 32022: 22023: 62024: 52026: 1
2001high 9 (2009) · low 0 (2002)2026

Most influential descendants

Showing 5 of 92 · See all
  • K002896Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 2001 · cites it directly83descendants
  • K024298Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2003 · 2 generations on53descendants
  • K032986Clo-Surplusp.a.D.Scion Cardio-Vascular, Inc. · 2004 · 3 generations on25descendants
  • K033869Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004 · 3 generations on17descendants
  • K041316Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2004 · 2 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000051Acticoat Foam DressingWestaim Biomedical, Inc.2000—
+1K002896Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp.2001—
+2K024298Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd.2003—
+3K032986Clo-Surplusp.a.D.Scion Cardio-Vascular, Inc.2004—
+3K033869Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp.2004—
+2K041316Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200320
200450
200520
200650
200730
200840
200990
201060
201120
201230
201340
201440
201580
201630
201730
201840
201940
202030
202130
202220
202360
202450
202610
FIG. 1 — Lineage of K000051, 2000–2026Source: 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.

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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (92)

See all 92

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

NumberDeviceApplicantDecidedDescendants
K002896Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp.200183
K050030Acticoat Moisture Control DressingSmith & Nephew, Inc.20059
K050086Brennen Medical Silver Glucan Wound DressingBrennen Medical, Inc.20060

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 15, 2003Not classifiedZ-0016-04OtherProduct may not meet the established stability specification before the end of labeled expiry date.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K002896 (The Westaim Corp., 2001) has gone furthest, with 83 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 Westaim Biomedical, Inc.

6 FDA decisions under this applicant name. See the company

  • K010447Modification to Acticoat Foam DressingWestaim Biomedical, Inc. · 2001
  • K002466Acticoat Composite DressingWestaim Biomedical, Inc. · 2001
  • K001519Acticoat 7 DressingWestaim Biomedical, Inc. · 2000
  • K992221Acticoat Primary Antimicrobial DressingWestaim Biomedical, Inc. · 2000
  • K983833Acticoat Composite Wound Dressing, Acticoat Composite Wound Dressing-AdhesiveWestaim Biomedical, Inc. · 1998

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/K000051 · printed Nov 5, 2026

Cite this page

510(k) Report. “K000051: Acticoat Foam Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K000051

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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