510(k) Report

510(k) · Cleared

Cleared

Silverseal

K033587510(k) TraditionalCleared Aug 5, 2004266-day reviewClass U

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

Noble Fiber Technologies · FRO Dressing, Wound, Drug

Cleared on Aug 5, 2004 as substantially equivalent to K970566 (Maersk Medical, Ltd., 1997) and 6 other predicates after a 266-day review. Its family tree reaches back 4 generations to 1992. 9 later devices descend from it.

Decided
Aug 5, 2004
Review
266 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
7

Its longest line of descent runs back 4 generations to K914579 (1992). 9 ancestors in all, the oldest K890354 (1989). 9 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 2 other ancestors1997: 1 other ancestor1989: 1 other ancestor1991: 1 other ancestor2005: 2 descendants cleared2007: 2 descendants cleared2009: 2 descendants cleared2024: 2 descendants cleared2023: 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 · 1998K984210 · Silverlon Wound Packing Strips · Argentum International, LLC · 19991990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant K984210 · Silverlon Wound Packing Strips · Argentum International, LLC · 1999K981299 · 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 · 4 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
  2. 3 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
  3. 2 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
  4. 1 generation backK984210 Silverlon Wound Packing StripsArgentum International, LLC · 1999
  5. This deviceK033587 SilversealNoble Fiber Technologies · 2004
  6. Descendant · cites it directly · 5 of its ownK050649 Silverseal Contacting Wound Dressing with X-StaticNoble Fiber Technologies, Inc. · 2005
  7. Descendant · 2 generations on · 3 of its ownK083133 Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing…Andover Healthcare, Inc. · 2009
  8. Descendant · cites it directly · 2 of its ownK050726 Silverseal Silveraid with X-StaticNoble Fiber Technologies, Inc. · 2005
  9. Descendant · 3 generations on · 1 of its ownK223360 LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd. · 2024
  10. Descendant · 2 generations on · 1 of its ownK072378 Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and…Arthrex, Inc. · 2007

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2005: 22007: 22009: 22023: 12024: 2
2005high 2 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 9 · See all
  • K050649Silverseal Contacting Wound Dressing with X-StaticNoble Fiber Technologies, Inc. · 2005 · cites it directly5descendants
  • K083133Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam…Andover Healthcare, Inc. · 2009 · 2 generations on3descendants
  • K050726Silverseal Silveraid with X-StaticNoble Fiber Technologies, Inc. · 2005 · cites it directly2descendants
  • K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2024 · 3 generations on1descendant
  • K072378Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625…Arthrex, Inc. · 2007 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K914579Silver Foam Wound DressingVitaphore Corp.1992—
−3K955453Acticoat Silver Coated DressingWestaim Technologies, Inc.1996—
−2K981299Silverlon Contact Wound DressingArgentum International, LLC1998—
−1K984210Silverlon Wound Packing StripsArgentum International, LLC1999—
0 (this device)K033587SilversealNoble Fiber Technologies2004—
+1K050649Silverseal Contacting Wound Dressing with X-StaticNoble Fiber Technologies, Inc.2005—
+2K083133Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex…Andover Healthcare, Inc.2009—
+1K050726Silverseal Silveraid with X-StaticNoble Fiber Technologies, Inc.2005—
+3K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial…Huizhou Foryou Medical Devices Co., Ltd.2024—
+2K072378Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models…Arthrex, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199110
199710
200320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200720
200920
202310
202420
FIG. 1 — Lineage of K033587, 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? (7)

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
*K970566Arglaes Film Dressing
Summary page 1
…gs are substantially equivalent in function and intended use to the following cleared contact wound dressings: Arglaes Film Dressing ([(970566), Acticoat Silver Coated Dressing ([(955453) , Silverlon Contact Wound Dressing (K981299) ([02361…
Maersk Medical, Ltd.1997—
*K955453Acticoat Silver Coated Dressing
Summary page 1
…and intended use to the following cleared contact wound dressings: Arglaes Film Dressing ([(970566), Acticoat Silver Coated Dressing ([(955453) , Silverlon Contact Wound Dressing (K981299) ([023612)([(023609) ([984210), and Tegapore Wound C…
Westaim Technologies, Inc.1996—
*K981299Silverlon Contact Wound Dressing
Summary page 1
…ntact wound dressings: Arglaes Film Dressing ([(970566), Acticoat Silver Coated Dressing ([(955453) , Silverlon Contact Wound Dressing (K981299) ([023612)([(023609) ([984210), and Tegapore Wound Contact Material (K890354). 10.1.4 Device Descriptio…
Argentum International, LLC1998—
*K023612Silverlon Contact Wound Dressing
Summary page 1
…dressings: Arglaes Film Dressing ([(970566), Acticoat Silver Coated Dressing ([(955453) , Silverlon Contact Wound Dressing (K981299) ([023612)([(023609) ([984210), and Tegapore Wound Contact Material (K890354). 10.1.4 Device Description…
Argentum International, LLC2003—
*K023609Silverlon Adhesive Strip
Summary page 1
…: Arglaes Film Dressing ([(970566), Acticoat Silver Coated Dressing ([(955453) , Silverlon Contact Wound Dressing (K981299) ([023612)([(023609) ([984210), and Tegapore Wound Contact Material (K890354). 10.1.4 Device Description…
Argentum International, LLC2003—
*K984210Silverlon Wound Packing Strips
Summary page 1
…s Film Dressing ([(970566), Acticoat Silver Coated Dressing ([(955453) , Silverlon Contact Wound Dressing (K981299) ([023612)([(023609) ([984210), and Tegapore Wound Contact Material (K890354). 10.1.4 Device Description…
Argentum International, LLC1999—
*K890354Tegapore Wound Contact Material, Product #563X
Summary page 1
…ated Dressing ([(955453) , Silverlon Contact Wound Dressing (K981299) ([023612)([(023609) ([984210), and Tegapore Wound Contact Material (K890354). 10.1.4 Device Description f hw te dvic Explnaton f…
3M Company1989—

Also cleared against K970566: 4 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K050649Silverseal Contacting Wound Dressing with X-StaticNoble Fiber Technologies, Inc.20055
K050726Silverseal Silveraid with X-StaticNoble Fiber Technologies, Inc.20052
K063190Silverseal Wound Packing Strips with X-StaticNoble Fiber Technologies, Inc.20070

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 12 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
  • None of the 9 ancestors has a recall.
  • Of its descendants, K050649 (Noble Fiber Technologies, Inc., 2005) has gone furthest, with 5 descendants of its own.
  • 4 other devices also cite its predicate K970566.

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?

X-Static® SILVERSEAL" Contact Wound Dressings are sterile, non-adherent dressings intended for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).

Indications for use as stated in the FDA summary.

Also cleared against K970566

4 other devices cite the same predicate.

  • K041268Silversite or CalgitrolAdri · 2004
  • K004028Arglaes-AB Antimicrobial Barrier Powder DressingMaersk Medical, Ltd. · 2001
  • K990810Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingMaersk Medical, Ltd. · 1999
  • K981299Silverlon Contact Wound DressingArgentum International, LLC · 1998

More from Noble Fiber Technologies

3 FDA decisions under this applicant name. See the company

  • K033900X-Static Silverseal Hydrocolloid Film and Island DressingNoble Fiber Technologies · 2005
  • K040019SilversealNoble Fiber Technologies · 2004

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/K033587 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033587: Silverseal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033587

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