510(k) · Cleared
ClearedD-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix Silver
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, Inc. · QSX Hemostatic Wound Dressing With Thrombin Or Other Biologics
Cleared on Apr 8, 2011 as substantially equivalent to K061219 (Vascular Solutions, Inc., 2006) and 5 other predicates after a 245-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Apr 8, 2011
- Review
- 245 days
- Class
- Class U
- Product code
- QSX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K953781 (1995). 43 ancestors in all, the oldest K896068 (1990). No later device cites it as a predicate yet.
- Root · 8 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 7 generations backK980989 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingInnovative Technologies, Ltd. · 1998
- 6 generations backK010933 Seal-on Topical Hempstatic Powder SprayAlltracel Pharma, Ltd. · 2002
- 5 generations backK024107 Femostop Femoral Compression SystemRadi Medical Systems AB · 2002
- 4 generations backK040730 Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc. · 2004
- 3 generations backK050146 Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005
- 2 generations backK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006
- 1 generation backK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
- This deviceK102212 D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver…Vascular Solutions, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K953781 | Innovative Technologies Calcium Alginate Wound Dressings | Innovative Technologies, Ltd. | 1995 | — |
| −7 | K980989 | 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing | Innovative Technologies, Ltd. | 1998 | — |
| −6 | K010933 | Seal-on Topical Hempstatic Powder Spray | Alltracel Pharma, Ltd. | 2002 | — |
| −5 | K024107 | Femostop Femoral Compression System | Radi Medical Systems AB | 2002 | — |
| −4 | K040730 | Vascular Solutions D-Stat Clamp Hemostatic Clamp | Vascular Solutions, Inc. | 2004 | — |
| −3 | K050146 | Vascular Solutions D-Stat Clamp Accessory | Vascular Solutions, Inc. | 2005 | — |
| −2 | K053300 | Syvekexcel | Marine Polymer Technologies, Inc. | 2006 | — |
| −1 | K061219 | D-Stat Dry Hemostatic Bandage | Vascular Solutions, Inc. | 2006 | — |
| 0 (this device) | K102212 | D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix… | Vascular Solutions, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 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 QSX? 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 QSX device
- #1 K200720 D-Stat Radial Topical Hemostatscore 0.8 · 5 generations · no Class I recall
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K061219 | D-Stat Dry Hemostatic BandageSummary page 8…ver, D-Stat Dry Wrap Silver, Thrombix Silver Common / Usual Name: Topical Hemostat Classification Name: Dressing, Wound, Drug Identification of Equivalent Devices: K061219 D-Stat Dry (Vascular Solutions, Inc.) K073264 D-Stat Dry Clear (Vascular Solutions, Inc.) K083 190 D-Stat Dry Wrap (Vascula… | 2006 |
| * | K073264 | D-Stat Dry Clear Hemostatic Bandage, Model 3005Summary page 8…mon / Usual Name: Topical Hemostat Classification Name: Dressing, Wound, Drug Identification of Equivalent Devices: K061219 D-Stat Dry (Vascular Solutions, Inc.) K073264 D-Stat Dry Clear (Vascular Solutions, Inc.) K083 190 D-Stat Dry Wrap (Vascular Solutions, Inc.) K072 117 Thrombix (Vascular… | 2007 |
| * | K083190 | D-Stat Dry Wrap Hemostatic Bandage, Model: 3015Summary page 8…: Dressing, Wound, Drug Identification of Equivalent Devices: K061219 D-Stat Dry (Vascular Solutions, Inc.) K073264 D-Stat Dry Clear (Vascular Solutions, Inc.) K083 190 D-Stat Dry Wrap (Vascular Solutions, Inc.) K072 117 Thrombix (Vascular Solutions, Inc.) K041268 Silver Alginate Foam Dressi… | 2008 |
| * | K072117 | Thrombix Patch Thrombin Hemostasis PatchSummary page 8…evices: K061219 D-Stat Dry (Vascular Solutions, Inc.) K073264 D-Stat Dry Clear (Vascular Solutions, Inc.) K083 190 D-Stat Dry Wrap (Vascular Solutions, Inc.) K072 117 Thrombix (Vascular Solutions, Inc.) K041268 Silver Alginate Foam Dressing (ADRI) K090254 Silver Hydrofiber* Dressing Reinfo… | 2007 |
| * | K041268 | Silversite or CalgitrolSummary page 8…s, Inc.) K073264 D-Stat Dry Clear (Vascular Solutions, Inc.) K083 190 D-Stat Dry Wrap (Vascular Solutions, Inc.) K072 117 Thrombix (Vascular Solutions, Inc.) K041268 Silver Alginate Foam Dressing (ADRI) K090254 Silver Hydrofiber* Dressing Reinforced with Nylon (ConvaTec, Inc.) Intended Use… | 2004 |
| * | K090254 | Silver Impregnated Hydrofiber Dressing Reinforced with Nylon (Flat)Summary page 8…olutions, Inc.) K083 190 D-Stat Dry Wrap (Vascular Solutions, Inc.) K072 117 Thrombix (Vascular Solutions, Inc.) K041268 Silver Alginate Foam Dressing (ADRI) K090254 Silver Hydrofiber* Dressing Reinforced with Nylon (ConvaTec, Inc.) Intended Use The fl-Stat Dry Silver and fl-Stat Dry Clear Sil… | 2009 |
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 16 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 43 ancestors has a recall of any class.
- 3 other devices also cite its predicate K061219.
How does its category compare?
All QSX devicesQSX Hemostatic Wound Dressing With Thrombin Or Other Biologics: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · QSX
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · QSX
56in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QSX
No recall names QSX since 2007.
Adverse event reports per year · QSX
No MAUDE report names QSX since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 56 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Applied topically as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes and reducing the time-to-hemostasis in patients undergoing diagnostic endovascular procedures utilizing 4-6 Fr. introducer sheaths. D-Stat Dry Clear Silver contains silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad. Applied…
Read the full statement (215 words)
Applied topically as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes and reducing the time-to-hemostasis in patients undergoing diagnostic endovascular procedures utilizing 4-6 Fr. introducer sheaths. D-Stat Dry Clear Silver contains silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad.
Applied topically as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes and reducing the time-to-hemostasis in patients undergoing diagnostic endovascular procedures utilizing 4-6 Fr. introducer sheaths. D-Stat Dry Silver contains silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad.
Applied topically as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes. D-Stat Dry Wrap Silver contains silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad.
Applied topically as an adjunct to manual compression and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes. Thrombix Silver contains silver chloride to prevent microorganisms commonly encountered in the clinical setting from colonizing on the pad.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102212: D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix Silver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102212
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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