510(k) · Cleared
ClearedVascular Solutions D-Stat Dry 3X3 Hemostatic Pad
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 Mar 17, 2004 after a 19-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Mar 17, 2004
- Review
- 19 days
- Class
- Class U
- Product code
- QSX
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK040510 Vascular Solutions D-Stat Dry 3X3 Hemostatic PadVascular Solutions, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK072117 Thrombix Patch Thrombin Hemostasis PatchVascular Solutions, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK083190 D-Stat Dry Wrap Hemostatic Bandage, Model: 3015Vascular Solutions, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK102212 D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver…Vascular Solutions, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK053054 Thrombix 3X3 Hemostatic PadVascular Solutions, Inc. · 2005
Most influential descendants
Showing 4 of 4 · See all- K072117Thrombix Patch Thrombin Hemostasis PatchVascular Solutions, Inc. · 2007 · cites it directly2descendants
- K083190D-Stat Dry Wrap Hemostatic Bandage, Model: 3015Vascular Solutions, Inc. · 2008 · 2 generations on1descendant
- K102212D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix SilverVascular Solutions, Inc. · 2011 · 2 generations on0descendants
- K053054Thrombix 3X3 Hemostatic PadVascular Solutions, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040510 | Vascular Solutions D-Stat Dry 3X3 Hemostatic Pad | Vascular Solutions, Inc. | 2004 | — |
| +1 | K072117 | Thrombix Patch Thrombin Hemostasis Patch | Vascular Solutions, Inc. | 2007 | — |
| +2 | K083190 | D-Stat Dry Wrap Hemostatic Bandage, Model: 3015 | Vascular Solutions, Inc. | 2008 | — |
| +2 | K102212 | D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix… | Vascular Solutions, Inc. | 2011 | — |
| +1 | K053054 | Thrombix 3X3 Hemostatic Pad | Vascular Solutions, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 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? (3)
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 |
|---|---|---|---|
| * | — | Vascular Solutions Inc., D-Stat Dry Hemostatic Bandage Named without a submission number | |
| * | — | On Site Gas Systems, Inc., QuikClot Named without a submission number | |
| * | — | Marine Polymer Technologies, Inc. RDH Bandage Named without a submission number |
What descends from it? (4)
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?
- Of its descendants, K072117 (Vascular Solutions, Inc., 2007) has gone furthest, with 2 descendants of its own.
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 3X3 is applied topically and is indicated as a trauma dressing for temporary control of moderate to severely bleeding wounds and for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040510 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040510: Vascular Solutions D-Stat Dry 3X3 Hemostatic Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040510
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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