510(k) Report

510(k) · Cleared

Cleared

Acticoat 7 Dressing

K001519510(k) TraditionalCleared Oct 6, 2000143-day reviewClass U

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 Oct 6, 2000 after a 143-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 70 later devices descend from it.

Decided
Oct 6, 2000
Review
143 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 6 descendants cleared2005: 4 descendants cleared2009: 4 descendants cleared2002: 1 descendant cleared2004: 1 descendant cleared2007: 3 descendants cleared2014: 8 descendants cleared2010: 7 descendants cleared2011: 5 descendants cleared2016: 4 descendants cleared2013: 2 descendants cleared2008: 1 descendant cleared2015: 3 descendants cleared2017: 3 descendants cleared2012: 2 descendants cleared2024: 6 descendants cleared2018: 4 descendants cleared2022: 2 descendants cleared2019: 2 descendants cleared2023: 2 descendants cleared200020052010201520202025
  1. This deviceK001519 Acticoat 7 DressingWestaim Biomedical, Inc. · 2000
  2. Descendant · cites it directly · 22 of its ownK083113 Acticoat Flex 7 DressingSmith & Nephew, Inc. · 2009
  3. Descendant · 2 generations on · 13 of its ownK122817 Silverlon Island Wound DressingArgentum Medical, LLC · 2014
  4. Descendant · cites it directly · 13 of its ownK013525 Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4…Coloplast Corp. · 2002
  5. Descendant · cites it directly · 12 of its ownK083870 Exsalt SD7 Wound DressingExciton Technologies, Inc. · 2009
  6. Descendant · cites it directly · 8 of its ownK041642 V.a.C. Granufoam Silver DressingKinetic Concepts, Inc. · 2005

Showing 5 of 70 descendants. See all descendants

Descendants cleared per year

2002: 12004: 12005: 42006: 62007: 32008: 12009: 42010: 72011: 52012: 22013: 22014: 82015: 32016: 42017: 32018: 42019: 22022: 22023: 22024: 6
2002high 8 (2014) · low 0 (2003)2026

Most influential descendants

Showing 5 of 70 · See all
  • K083113Acticoat Flex 7 DressingSmith & Nephew, Inc. · 2009 · cites it directly22descendants
  • K122817Silverlon Island Wound DressingArgentum Medical, LLC · 2014 · 2 generations on13descendants
  • K013525Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613…Coloplast Corp. · 2002 · cites it directly13descendants
  • K083870Exsalt SD7 Wound DressingExciton Technologies, Inc. · 2009 · cites it directly12descendants
  • K041642V.a.C. Granufoam Silver DressingKinetic Concepts, Inc. · 2005 · cites it directly8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001519Acticoat 7 DressingWestaim Biomedical, Inc.2000—
+1K083113Acticoat Flex 7 DressingSmith & Nephew, Inc.2009—
+2K122817Silverlon Island Wound DressingArgentum Medical, LLC2014—
+1K013525Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X…Coloplast Corp.2002—
+1K083870Exsalt SD7 Wound DressingExciton Technologies, Inc.2009—
+1K041642V.a.C. Granufoam Silver DressingKinetic Concepts, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
200540
200660
200730
200810
200940
201070
201150
201220
201320
201480
201530
201640
201730
201840
201920
202220
202320
202460
FIG. 1 — Lineage of K001519, 2000–2024Source: 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), 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
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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? (70)

See all 70

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

NumberDeviceApplicantDecidedDescendants
K083113Acticoat Flex 7 DressingSmith & Nephew, Inc.200922
K013525Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613…Coloplast Corp.200213
K083870Exsalt SD7 Wound DressingExciton Technologies, Inc.200912
K041642V.a.C. Granufoam Silver DressingKinetic Concepts, Inc.20058
K061220Urgotul AGLaboratoires Urgo20067
K051542Triosyn T40 Antimicrobial Wound DressingTriosyn Corp.20066
K051445Milliken Silver Wound DressingsMilliken Chemical20053
K033900X-Static Silverseal Hydrocolloid Film and Island DressingNoble Fiber Technologies20052
K050086Brennen Medical Silver Glucan Wound DressingBrennen Medical, Inc.20060

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, K083113 (Smith & Nephew, Inc., 2009) has gone furthest, with 22 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
  • K992221Acticoat Primary Antimicrobial DressingWestaim Biomedical, Inc. · 2000
  • K000051Acticoat Foam DressingWestaim Biomedical, Inc. · 20001 recall
  • 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/K001519 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001519: Acticoat 7 Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001519

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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