510(k) Report

510(k) · Cleared

Cleared

X-Static Silverseal Hydrocolloid Film and Island Dressing

K033900510(k) TraditionalCleared Jan 14, 2005394-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 Jan 14, 2005 as substantially equivalent to K990810 (Maersk Medical, Ltd., 1999) and 4 other predicates after a 394-day review. Its family tree reaches back 3 generations to 1997. 2 later devices descend from it.

Decided
Jan 14, 2005
Review
394 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K970566 (1997). 10 ancestors in all, the oldest K940624 (1994). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1998: 2 other ancestors1997: 2 other ancestors1994: 2 other ancestors2007: 1 descendant cleared2009: 1 descendant clearedK970566 · Arglaes Film Dressing · Maersk Medical, Ltd. · 1997K990810 · Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing · Maersk Medical, Ltd. · 1999K013525 · Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) · Coloplast Corp. · 20021990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K013525 · Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM) · Coloplast Corp. · 2002K990810 · Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing · Maersk Medical, Ltd. · 1999K970566 · Arglaes Film Dressing · Maersk Medical, Ltd. · 19970
  1. Root · 3 generations backK970566 Arglaes Film DressingMaersk Medical, Ltd. · 1997
  2. 2 generations backK990810 Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingMaersk Medical, Ltd. · 1999
  3. 1 generation backK013525 Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4…Coloplast Corp. · 2002
  4. This deviceK033900 X-Static Silverseal Hydrocolloid Film and Island DressingNoble Fiber Technologies · 2005
  5. Descendant · cites it directly · 1 of its ownK072378 Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and…Arthrex, Inc. · 2007
  6. Descendant · 2 generations on · 0 of its ownK083007 ProwickArthrex, Inc. · 2009

Most influential descendants

Showing 2 of 2 · See all
  • K072378Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625…Arthrex, Inc. · 2007 · cites it directly1descendant
  • K083007ProwickArthrex, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K970566Arglaes Film DressingMaersk Medical, Ltd.1997—
−2K990810Arglaes-AB Antimicrobial Barrier Film Dressing & Island DressingMaersk Medical, Ltd.1999—
−1K013525Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X…Coloplast Corp.2002—
0 (this device)K033900X-Static Silverseal Hydrocolloid Film and Island DressingNoble Fiber Technologies2005—
+1K072378Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models…Arthrex, Inc.2007—
+2K083007ProwickArthrex, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
199720
199820
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200910
FIG. 1 — Lineage of K033900, 1997–2009Source: 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? (5)

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
*K990810Arglaes-AB Antimicrobial Barrier Film Dressing & Island Dressing
Our reading of the summary gave K990310, FDA’s number for Charter Medical, LTD MP 450 (40 Micron Filter) (Charter Medical, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Arqlaes Film Dressing”.
Maersk Medical, Ltd.1999—
*K001519Acticoat 7 Dressing
Summary page 1
…following cleared Hydrocolloid Film and Island Dressings: Arqlaes Film Dressing (R990310, Maersk Medical, Ltd.), ActicoatY' 7 Dressing (KO001519, Westaim Technologies, Inc.), Tegaporet m Hydrocolloid Dressing (K982893, 3M Health Care), Hydrocollo-id &…
Westaim Biomedical, Inc.2000—
*K9828933M Tegasorb Hydrocolloid Dressing
Summary page 1
…Dressing (R990310, Maersk Medical, Ltd.), ActicoatY' 7 Dressing (KO001519, Westaim Technologies, Inc.), Tegaporet m Hydrocolloid Dressing (K982893, 3M Health Care), Hydrocollo-id & Intelligent Hydrocolloid Wound Dressing (K•983303, Innovative Tec…
3M Company1998—
*K983303Innovative Technologies Hydrocolloid and Intelligent Hydrocolloid Wound Dressings
Summary page 1
…echnologies, Inc.), Tegaporet m Hydrocolloid Dressing (K982893, 3M Health Care), Hydrocollo-id & Intelligent Hydrocolloid Wound Dressing (K•983303, Innovative Technologies, Limited), and Contreet Hydrocolloid Dressing (K(013525, Coloplast Corpora…
Innovative Technologies, Ltd.1998—
*K013525Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613…
Summary page 1
…Intelligent Hydrocolloid Wound Dressing (K•983303, Innovative Technologies, Limited), and Contreet Hydrocolloid Dressing (K(013525, Coloplast Corporation). 10.1.4 Device Description Explanation of how the device functions: X-Static® SIL…
Coloplast Corp.2002—

Also cleared against K990810: 7 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K072378Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625…Arthrex, Inc.20071

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 8 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
  • None of the 10 ancestors has a recall.
  • Of its descendants, K072378 (Arthrex, Inc., 2007) has gone furthest, with 1 descendant of its own.
  • 7 other devices also cite its predicate K990810.

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 Hydrocolloid Film and Island Dressings are indicated for: partial and full thickness dermal ulcers, leg ulcers (vascular, venous, pressure and diabetic), superficial wounds, abrasions, first and second degree burns, and donor sites.

Indications for use as stated in the FDA summary.

Also cleared against K990810

7 other devices cite the same predicate.

  • K121819Surgiclear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverCovalontechnologies, Inc. · 2012
  • K112549IV Clear Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and SilverCovalontechnologies, Inc. · 2012
  • K041268Silversite or CalgitrolAdri · 2004
  • K033453Kendall Ultec Pro AG+ Hydrocolloid DressingTyco Healthcare · 2004
  • K024054Xylos Xcell Antimicrobial DressingXylos Corporation · 2003
  • K013525Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613 (6X6 (15CM X 15CM)Coloplast Corp. · 2002

More from Noble Fiber Technologies

3 FDA decisions under this applicant name. See the company

  • K033587SilversealNoble Fiber Technologies · 2004
  • 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/K033900 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033900: X-Static Silverseal Hydrocolloid Film and Island Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033900

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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