510(k) · Cleared
ClearedSilverseal Wound Packing Strips with X-Static
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Noble Fiber Technologies, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Cleared on Aug 21, 2007 as substantially equivalent to K984210 (Argentum International, LLC, 1999) and 4 other predicates after a 305-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Aug 21, 2007
- Review
- 305 days
- Class
- Class U
- Product code
- QSY
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K914579 (1992). 13 ancestors in all, the oldest K890354 (1989). No later device cites it as a predicate yet.
- Root · 6 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 5 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 4 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 3 generations backK984210 Silverlon Wound Packing StripsArgentum International, LLC · 1999
- 2 generations backK033587 SilversealNoble Fiber Technologies · 2004
- 1 generation backK050649 Silverseal Contacting Wound Dressing with X-StaticNoble Fiber Technologies, Inc. · 2005
- This deviceK063190 Silverseal Wound Packing Strips with X-StaticNoble Fiber Technologies, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −5 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −4 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −3 | K984210 | Silverlon Wound Packing Strips | Argentum International, LLC | 1999 | — |
| −2 | K033587 | Silverseal | Noble Fiber Technologies | 2004 | — |
| −1 | K050649 | Silverseal Contacting Wound Dressing with X-Static | Noble Fiber Technologies, Inc. | 2005 | — |
| 0 (this device) | 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 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 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 QSY? 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 QSY device
- #1 K240713 Traumagel®score 15.1 · 5 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K984210 | Silverlon Wound Packing StripsSummary page 5…tective dressing consisting of nylon fibers with a metallic silver surface. It is substantially equivalent to Silverlon Wound Packing Strip (K984210), Dynarex Iodoform Packing Strip (K012816), Medline Wound Packing Strip (K052720); SILVERSEAL® Contac… | 1999 |
| * | K012816 | Dynarex Iodoform Packing Strips, Models 3411, 3412, 3413, 3414Summary page 5…a metallic silver surface. It is substantially equivalent to Silverlon Wound Packing Strip (K984210), Dynarex Iodoform Packing Strip (K012816), Medline Wound Packing Strip (K052720); SILVERSEAL® Contact Wound Dressing with X-Static® (K033587),… | 2002 |
| * | K052720 | Medline Iodoform Packing StripsSummary page 5…s substantially equivalent to Silverlon Wound Packing Strip (K984210), Dynarex Iodoform Packing Strip (K012816), Medline Wound Packing Strip (K052720); SILVERSEAL® Contact Wound Dressing with X-Static® (K033587), Silverseal® Burn Dressing with X-Stati… | 2005 |
| * | K033587 | SilversealSummary page 5…K984210), Dynarex Iodoform Packing Strip (K012816), Medline Wound Packing Strip (K052720); SILVERSEAL® Contact Wound Dressing with X-Static® (K033587), Silverseal® Burn Dressing with X-Static (K050649), with respect to functional design, performance,… | 2004 |
| * | K050649 | Silverseal Contacting Wound Dressing with X-StaticSummary page 5…Medline Wound Packing Strip (K052720); SILVERSEAL® Contact Wound Dressing with X-Static® (K033587), Silverseal® Burn Dressing with X-Static (K050649), with respect to functional design, performance, and intended use as these presently distributed dev… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- None of the 13 ancestors has a recall.
- 2 other devices also cite its predicate K984210.
How does its category compare?
All QSY devicesQSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · QSY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QSY
142in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QSY
No recall names QSY since 2007.
Adverse event reports per year · QSY
14in 2025
MAUDE reports naming product code QSY, 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 | 13 | 63 | 0 | 0 |
| 2008 | 7 | 61 | 0 | 0 |
| 2009 | 9 | 55 | 0 | 0 |
| 2010 | 7 | 75 | 0 | 0 |
| 2011 | 8 | 137 | 0 | 0 |
| 2012 | 7 | 239 | 0 | 0 |
| 2013 | 3 | 161 | 0 | 0 |
| 2014 | 6 | 249 | 0 | 0 |
| 2015 | 6 | 171 | 0 | 0 |
| 2016 | 5 | 161 | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 5 | 186 | 0 | 0 |
| 2019 | 4 | 336 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 7 | 586 | 0 | 0 |
| 2024 | 4 | 142 | 0 | 3 |
| 2025 | 2 | — | 0 | 14 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Silverseal® Wound Packing Strips with X-Static® are intended for the control of local wound bleeding and nasal hemorrhage, and to encourage draining by wicking fluids from a body cavity, infected area, or abscess, and to help remove necrotic tissue from ulcers or other infected wounds when used as a wet-to-dry packing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063190 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063190: Silverseal Wound Packing Strips 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/K063190
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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