510(k) · Cleared
ClearedD-Stat Dry Hemostatic Bandage
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 Oct 6, 2006 as substantially equivalent to K030836 (Vascular Solutions, Inc., 2003) and 1 other predicate after a 158-day review. Its family tree reaches back 7 generations to 1995. 13 later devices descend from it.
- Decided
- Oct 6, 2006
- Review
- 158 days
- Class
- Class U
- Product code
- QSX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K953781 (1995). 26 ancestors in all, the oldest K896068 (1990). 13 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 6 generations backK980989 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingInnovative Technologies, Ltd. · 1998
- 5 generations backK010933 Seal-on Topical Hempstatic Powder SprayAlltracel Pharma, Ltd. · 2002
- 4 generations backK024107 Femostop Femoral Compression SystemRadi Medical Systems AB · 2002
- 3 generations backK040730 Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc. · 2004
- 2 generations backK050146 Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005
- 1 generation backK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006
- This deviceK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
- Descendant · cites it directly · 5 of its ownK090620 Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009
- Descendant · cites it directly · 5 of its ownK072890 Stasilon FREntegrion, Inc. · 2007
- Descendant · 2 generations on · 4 of its ownK142363 Nustat, Nustat XRBeeken Biomedical · 2015
- Descendant · 3 generations on · 2 of its ownK222189 SiOxD Wound MatrixSioxmed, LLC · 2022
- Descendant · cites it directly · 2 of its ownK093519 Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd. · 2010
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009 · cites it directly5descendants
- K072890Stasilon FREntegrion, Inc. · 2007 · cites it directly5descendants
- K142363Nustat, Nustat XRBeeken Biomedical · 2015 · 2 generations on4descendants
- K222189SiOxD Wound MatrixSioxmed, LLC · 2022 · 3 generations on2descendants
- K093519Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd. · 2010 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K953781 | Innovative Technologies Calcium Alginate Wound Dressings | Innovative Technologies, Ltd. | 1995 | — |
| −6 | K980989 | 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing | Innovative Technologies, Ltd. | 1998 | — |
| −5 | K010933 | Seal-on Topical Hempstatic Powder Spray | Alltracel Pharma, Ltd. | 2002 | — |
| −4 | K024107 | Femostop Femoral Compression System | Radi Medical Systems AB | 2002 | — |
| −3 | K040730 | Vascular Solutions D-Stat Clamp Hemostatic Clamp | Vascular Solutions, Inc. | 2004 | — |
| −2 | K050146 | Vascular Solutions D-Stat Clamp Accessory | Vascular Solutions, Inc. | 2005 | — |
| −1 | K053300 | Syvekexcel | Marine Polymer Technologies, Inc. | 2006 | — |
| 0 (this device) | K061219 | D-Stat Dry Hemostatic Bandage | Vascular Solutions, Inc. | 2006 | — |
| +1 | K090620 | Quikclot Inteventional, Model P/N 182 | Z-Medica Corporation | 2009 | — |
| +1 | K072890 | Stasilon FR | Entegrion, Inc. | 2007 | — |
| +2 | K142363 | Nustat, Nustat XR | Beeken Biomedical | 2015 | — |
| +3 | K222189 | SiOxD Wound Matrix | Sioxmed, LLC | 2022 | — |
| +1 | K093519 | Medtrade Products Celox Vascular Topical Hemostatic Granules on Sheet | Medtrade Products, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K030836 | D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageSummary page 6…e intended study population was safe and reduced the time-to-hemostasis following diagnostic catheterization procedures. Predicate Devices: D-Stat DryTM Dry Hemostatic - K030836 Syvek exce Vascular Access Hemostasis System - K053300 Conclusions: The D-Stat DryTM Hemostatic Bandage is substantially equivale… | 2003 |
| * | K053300 | SyvekexcelSummary page 6…me-to-hemostasis following diagnostic catheterization procedures. Predicate Devices: D-Stat DryTM Dry Hemostatic - K030836 Syvek exce Vascular Access Hemostasis System - K053300 Conclusions: The D-Stat DryTM Hemostatic Bandage is substantially equivalent to the D-Stat DryTM Hemostatic Bandage, based on com… | 2006 |
What descends from it? (13)
See all 134 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 11 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K090620 (Z-Medica Corporation, 2009) has gone furthest, with 5 descendants of its own.
- 7 other devices also cite its predicate K030836.
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.
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?
The D-Stat Dry is 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061219 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061219: D-Stat Dry Hemostatic Bandage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061219
Report an extraction error
Are you the manufacturer?
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