510(k) · Cleared
ClearedSilverseal Silveraid 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 Dec 5, 2005 as substantially equivalent to K033587 (Noble Fiber Technologies, 2004) and 2 other predicates after a 262-day review. Its family tree reaches back 5 generations to 1992. 2 later devices descend from it.
- Decided
- Dec 5, 2005
- Review
- 262 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K914579 (1992). 10 ancestors in all, the oldest K890354 (1989). 2 later devices descend from it, 1 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 deviceK050726 Silverseal Silveraid with X-StaticNoble Fiber Technologies, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK072378 Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and…Arthrex, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK083007 ProwickArthrex, Inc. · 2009
Most influential descendants
Showing 2 of 2 · See allView 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) | K050726 | Silverseal Silveraid with X-Static | Noble Fiber Technologies, Inc. | 2005 | — |
| +1 | K072378 | Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models… | Arthrex, Inc. | 2007 | — |
| +2 | K083007 | Prowick | Arthrex, Inc. | 2009 | — |
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 |
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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033587 | SilversealSummary page 1…fibers with a metallic silver surface. It is substantially equivalont to SILVERSEALY Contact Wound Dressing with X-Static~ (K033587), Silverion Adhesive Strips and Wound Contact Dressings (K023612, Eq:i2q9, K023609), an… | 2004 |
| * | K023612 | Silverlon Contact Wound DressingSummary page 1…ly equivalont to SILVERSEALY Contact Wound Dressing with X-Static~ (K033587), Silverion Adhesive Strips and Wound Contact Dressings (K023612, Eq:i2q9, K023609), and Curad Cilver Randage (K03246}) with… | 2003 |
| Kept off the family tree | K023629 | FDA’s K023629 is Essex Dissection Cannula, Model SXD-1100, Essex Dissection Tip, Model SXD-1200 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2002 |
| * | K023609 | Silverlon Adhesive StripSummary page 1…RSEALY Contact Wound Dressing with X-Static~ (K033587), Silverion Adhesive Strips and Wound Contact Dressings (K023612, Eq:i2q9, K023609), and Curad Cilver Randage (K03246}) with resoect to function, intended use,… | 2003 |
| Kept off the family tree | K032461 | FDA’s K032461 is Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221 Our reading of the summary gave K032461, FDA’s number for Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221 (Lin-Zhi International, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Curad Silver Bandage”. Kept off the family tree. | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072378 | Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625… | 2007 | 1 |
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, K072378 (Arthrex, Inc., 2007) has gone furthest, with 1 descendant 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® Adhesive Strips with X-Static® may be used for:
First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.
Under the supervision of a health care professional, SILVERSEAL® Adhesive Strips may be used for the management of:
SILVERSEAL Adhesive Strips with X-Static 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.
https://510kreport.com/device/K050726 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050726: Silverseal Silveraid with X-Static.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050726
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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