510(k) · Cleared
ClearedSilverseal Contacting Wound Dressing with X-Static
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Noble Fiber Technologies, Inc. · FRO Dressing, Wound, Drug
Cleared on Jun 13, 2005 as substantially equivalent to K033587 (Noble Fiber Technologies, 2004) and 1 other predicate after a 91-day review. Its family tree reaches back 5 generations to 1992. 5 later devices descend from it.
- Decided
- Jun 13, 2005
- Review
- 91 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K914579 (1992). 10 ancestors in all, the oldest K890354 (1989). 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 4 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 3 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 2 generations backK984210 Silverlon Wound Packing StripsArgentum International, LLC · 1999
- 1 generation backK033587 SilversealNoble Fiber Technologies · 2004
- This deviceK050649 Silverseal Contacting Wound Dressing with X-StaticNoble Fiber Technologies, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK083133 Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing…Andover Healthcare, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK223360 LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK242856 LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON®…Huizhou Foryou Medical Devices Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK223359 LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK063190 Silverseal Wound Packing Strips with X-StaticNoble Fiber Technologies, Inc. · 2007
Most influential descendants
Showing 5 of 5 · See all- K083133Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam…Andover Healthcare, Inc. · 2009 · cites it directly3descendants
- K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2024 · 2 generations on1descendant
- K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd. · 2024 · 3 generations on0descendants
- K223359LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2023 · 2 generations on0descendants
- K063190Silverseal Wound Packing Strips with X-StaticNoble Fiber Technologies, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −4 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −3 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −2 | K984210 | Silverlon Wound Packing Strips | Argentum International, LLC | 1999 | — |
| −1 | K033587 | Silverseal | Noble Fiber Technologies | 2004 | — |
| 0 (this device) | K050649 | Silverseal Contacting Wound Dressing with X-Static | Noble Fiber Technologies, Inc. | 2005 | — |
| +1 | K083133 | Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex… | Andover Healthcare, Inc. | 2009 | — |
| +2 | K223360 | LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial… | Huizhou Foryou Medical Devices Co., Ltd. | 2024 | — |
| +3 | K242856 | LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone… | Huizhou Foryou Medical Devices Co., Ltd. | 2024 | — |
| +2 | K223359 | LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2023 | — |
| +1 | K063190 | Silverseal Wound Packing Strips with X-Static | Noble Fiber Technologies, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
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 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033587 | SilversealSummary page 1…nylon fibers with a metallic silver surface. It is substantially equivalent to SILVERSEAL Contact Wound Dressing with X-Static® (K033587), and Silverlon" Contact Wound Dressing (K023612) with respect to function, intended use, and compo… | 2004 |
| * | K023612 | Silverlon Contact Wound DressingSummary page 1…substantially equivalent to SILVERSEAL Contact Wound Dressing with X-Static® (K033587), and Silverlon" Contact Wound Dressing (K023612) with respect to function, intended use, and composition. 10.1.4 Device Description Ex… | 2003 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K083133 (Andover Healthcare, Inc., 2009) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K033587.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
For over-the-counter use, Silverseal® Wound Contact Dressing with X-Static® may be used for first aid management of minor abrasions, cuts, scrapes, scalds and burns.
Under the supervision of a health care professional, Silverseal® Contact Wound Dressing may be used for the 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.
https://510kreport.com/device/K050649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050649: Silverseal Contacting Wound Dressing with X-Static.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050649
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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