510(k) Report

510(k) · Cleared

Cleared

Silverlon Direct Pressure Wound Closure Strip

K984204510(k) TraditionalCleared Mar 19, 20073,037-day reviewClass U

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

Argentum International, LLC · FRO Dressing, Wound, Drug

Cleared on Mar 19, 2007 as substantially equivalent to K813265 (3M Company, 1983) and 2 other predicates after a 3,037-day review. Its family tree reaches back 3 generations to 1992.

Decided
Mar 19, 2007
Review
3,037 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K914579 (1992). 7 ancestors in all, the oldest K813265 (1983). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1984: 1 other ancestor1983: 1 other ancestor1997: 1 other ancestor1989: 1 other ancestorK914579 · Silver Foam Wound Dressing · Vitaphore Corp. · 1992K955453 · Acticoat Silver Coated Dressing · Westaim Technologies, Inc. · 1996K981299 · Silverlon Contact Wound Dressing · Argentum International, LLC · 1998198019851990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors K981299 · Silverlon Contact Wound Dressing · Argentum International, LLC · 1998K955453 · Acticoat Silver Coated Dressing · Westaim Technologies, Inc. · 1996K914579 · Silver Foam Wound Dressing · Vitaphore Corp. · 19920
  1. Root · 3 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
  2. 2 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
  3. 1 generation backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
  4. This deviceK984204 Silverlon Direct Pressure Wound Closure StripArgentum International, LLC · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K914579Silver Foam Wound DressingVitaphore Corp.1992—
−2K955453Acticoat Silver Coated DressingWestaim Technologies, Inc.1996—
−1K981299Silverlon Contact Wound DressingArgentum International, LLC1998—
0 (this device)K984204Silverlon Direct Pressure Wound Closure StripArgentum International, LLC2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198410
198910
199710
FIG. 1 — Lineage of K984204, 1992–2007Source: 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? (3)

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
*K8132653M Steri-Strip Antimicrobial Skin Clos
Summary page 2
…DP Wound Closure Strip is substantially equivalent with respect to function, intended use, and composition to: (1) 3M Company, Steri-strip Antimicrobial barrier Skin (K813265); (2) Genetic Laboratories, Suture Strip™ Wound Closure Strip (K842621), (3) Silverlon™ Contact Wound Dressing (K981299) Dev…
3M Company1983—
*K842621Suture Strip
Summary page 2
…ion, intended use, and composition to: (1) 3M Company, Steri-strip Antimicrobial barrier Skin (K813265); (2) Genetic Laboratories, Suture Strip™ Wound Closure Strip (K842621), (3) Silverlon™ Contact Wound Dressing (K981299) Device Description Explanation of How the Device Functions: Silverlon™ DP W…
Genetic Laboratories, Inc.1984—
*K981299Silverlon Contact Wound Dressing
Summary page 2
…pany, Steri-strip Antimicrobial barrier Skin (K813265); (2) Genetic Laboratories, Suture Strip™ Wound Closure Strip (K842621), (3) Silverlon™ Contact Wound Dressing (K981299) Device Description Explanation of How the Device Functions: Silverlon™ DP Wound Closure Strips are designed to provide a balan…
Argentum International, LLC1998—

Also cleared against K813265: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
  • None of the 7 ancestors has a recall.
  • 1 other device also cites its predicate K813265.

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?

Silverlon™ Direct Pressure (DP) Wound Closure Strips are absorbent antimicrobial barrier dressings.

Local management of superficial wounds and skin tears and minor lacerations.

Primary or secondary closure following surgery, supplementary-support to sutures, staples or sealants, wound support following suture removal, and wound sites where suturing would aggravate bleeding.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K813265

1 other device cites the same predicate.

  • K112131Neodyne DressingNeodyne Biosciences, Inc. · 2011

More from Argentum International, LLC

8 FDA decisions under this applicant name. See the company

  • K984207Silverlon Direct Pressure Wound DressingArgentum International, LLC · 2007
  • K984205Silverlon Adhesive StripArgentum International, LLC · 2007
  • K023612Silverlon Contact Wound DressingArgentum International, LLC · 2003
  • K023609Silverlon Adhesive StripArgentum International, LLC · 2003
  • K984210Silverlon Wound Packing StripsArgentum International, LLC · 1999

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/K984204 · printed Nov 5, 2026

Cite this page

510(k) Report. “K984204: Silverlon Direct Pressure Wound Closure Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984204

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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