510(k) Report

510(k) · Cleared

Cleared

Silverlon Island Dressing, Silverlon Island Pad

K984208510(k) TraditionalCleared Feb 22, 199990-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 Feb 22, 1999 as substantially equivalent to K910657 (Deroyal Industries, Inc., 1991) and 1 other predicate after a 90-day review. Its family tree reaches back 3 generations to 1992. 14 later devices descend from it.

Decided
Feb 22, 1999
Review
90 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K914579 (1992). 6 ancestors in all, the oldest K890354 (1989). 14 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1991: 1 other ancestor1997: 1 other ancestor1989: 1 other ancestor2014: 4 descendants cleared2015: 1 descendant cleared2019: 2 descendants cleared2018: 2 descendants cleared2023: 1 descendant cleared2024: 3 descendants cleared2022: 1 descendant clearedK914579 · Silver Foam Wound Dressing · Vitaphore Corp. · 1992K955453 · Acticoat Silver Coated Dressing · Westaim Technologies, Inc. · 1996K981299 · Silverlon Contact Wound Dressing · Argentum International, LLC · 19981990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 4 descendants4 generations forward: 4 descendants5 generations forward: 1 descendant K981299 · Silverlon Contact Wound Dressing · Argentum International, LLC · 1998K955453 · Acticoat Silver Coated Dressing · Westaim Technologies, Inc. · 1996K914579 · Silver Foam Wound Dressing · Vitaphore Corp. · 19920+5
  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 deviceK984208 Silverlon Island Dressing, Silverlon Island PadArgentum International, LLC · 1999
  5. Descendant · cites it directly · 13 of its ownK122817 Silverlon Island Wound DressingArgentum Medical, LLC · 2014
  6. Descendant · 2 generations on · 5 of its ownK143001 Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical · 2014
  7. Descendant · 2 generations on · 4 of its ownK150256 Silverlon Burn Contact DressingsArgentum Medical · 2015
  8. Descendant · 3 generations on · 3 of its ownK190343 Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, LLC · 2019
  9. Descendant · 4 generations on · 1 of its ownK221218 Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc. · 2022

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2014: 42015: 12018: 22019: 22022: 12023: 12024: 3
2014high 4 (2014) · low 0 (2016)2026

Most influential descendants

Showing 5 of 14 · See all
  • K122817Silverlon Island Wound DressingArgentum Medical, LLC · 2014 · cites it directly13descendants
  • K143001Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical · 2014 · 2 generations on5descendants
  • K150256Silverlon Burn Contact DressingsArgentum Medical · 2015 · 2 generations on4descendants
  • K190343Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, LLC · 2019 · 3 generations on3descendants
  • K221218Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc. · 2022 · 4 generations on1descendant
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)K984208Silverlon Island Dressing, Silverlon Island PadArgentum International, LLC1999—
+1K122817Silverlon Island Wound DressingArgentum Medical, LLC2014—
+2K143001Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical2014—
+2K150256Silverlon Burn Contact DressingsArgentum Medical2015—
+3K190343Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, LLC2019—
+4K221218Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199110
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201440
201510
201820
201920
202210
202310
202430
FIG. 1 — Lineage of K984208, 1992–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (2)

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
*K910657Qualtex Island Dressing
Summary page 2
…4 being claimed Silverlon™ Island Wound Dressing is substantially equivalent with respect to function, intended use, and composition to: (1) Qualtex Island Dressing (K910657); (2) Silverlon™ Contact Wound Dressing (K981299). Device Description Explanation of how the device functiops: Silverlon™ Isla…
Deroyal Industries, Inc.1991—
*K981299Silverlon Contact Wound Dressing
Summary page 2
…is substantially equivalent with respect to function, intended use, and composition to: (1) Qualtex Island Dressing (K910657); (2) Silverlon™ Contact Wound Dressing (K981299). Device Description Explanation of how the device functiops: Silverlon™ Island Wound Dressings are designed to intimately cont…
Argentum International, LLC1998—

Also cleared against K910657: 1 other device →

What descends from it? (14)

See all 14

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K122817Silverlon Island Wound DressingArgentum Medical, LLC201413

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 7 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K122817 (Argentum Medical, LLC, 2014) has gone furthest, with 13 descendants of its own.
  • 1 other device also cites its predicate K910657.

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?

Silverlon™ Island Wound Dressings are multi-layer, sterile, non-adherent, antimicrobial barrier wound dressings.

The Over-The-Counter indications:

Local management of superficial wounds, minor burns, abrasions and lacerations.

The Prescription Professional indications:

Wounds such as vascular access or peripheral IV sites, orthopaedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions), and partial to full thickness dermal ulcers (Stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers).

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 K910657

1 other device cites the same predicate.

  • K023609Silverlon Adhesive StripArgentum International, LLC · 2003

More from Argentum International, LLC

8 FDA decisions under this applicant name. See the company

  • K984207Silverlon Direct Pressure Wound DressingArgentum International, LLC · 2007
  • K984204Silverlon Direct Pressure Wound Closure StripArgentum International, LLC · 2007
  • K984205Silverlon Adhesive StripArgentum International, LLC · 2007
  • K023612Silverlon Contact Wound DressingArgentum International, LLC · 2003
  • K023609Silverlon Adhesive StripArgentum International, LLC · 2003

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/K984208 · printed Nov 6, 2026

Cite this page

510(k) Report. “K984208: Silverlon Island Dressing, Silverlon Island Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984208

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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