510(k) · Cleared
Recalled · 2005D-Stat-Dry Hemostatic Bandage; D-Stat Radial 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 Sep 17, 2003 as substantially equivalent to K012293 (Vascular Solutions, Inc., 2002) and 1 other predicate after a 184-day review. Its family tree reaches back 3 generations to 1990. 44 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 17, 2003
- Review
- 184 days
- Class
- Class U
- Product code
- QSX
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 3 generations to K896068 (1990). 4 ancestors in all. 44 later devices descend from it, 8 citing it directly.
- Root · 3 generations backK896068 Tipstop (TM)Gambro-Hospal, Inc. · 1990
- 2 generations backK982818 Hospal TipstopGambro Healthcare · 1998
- 1 generation backK012293 Vascular Solutions Duett Flowable HemostatVascular Solutions, Inc. · 2002
- This deviceK030836 D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc. · 2003
- Descendant · cites it directly · 25 of its ownK050511 Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc. · 2005
- Descendant · 2 generations on · 19 of its ownK072900 Excelarrest FoamHemostasis, LLC · 2007
- Descendant · cites it directly · 16 of its ownK050146 Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005
- Descendant · cites it directly · 14 of its ownK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006
- Descendant · cites it directly · 13 of its ownK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K050511Thrombigel Thrombin/Gelatin Foam HemostatVascular Solutions, Inc. · 2005 · cites it directly25descendants
- K072900Excelarrest FoamHemostasis, LLC · 2007 · 2 generations on19descendants
- K050146Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005 · cites it directly16descendants
- K053300SyvekexcelMarine Polymer Technologies, Inc. · 2006 · cites it directly14descendants
- K061219D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006 · cites it directly13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K896068 | Tipstop (TM) | Gambro-Hospal, Inc. | 1990 | — |
| −2 | K982818 | Hospal Tipstop | Gambro Healthcare | 1998 | — |
| −1 | K012293 | Vascular Solutions Duett Flowable Hemostat | Vascular Solutions, Inc. | 2002 | — |
| 0 (this device) | K030836 | D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage | Vascular Solutions, Inc. | 2003 | — |
| +1 | K050511 | Thrombigel Thrombin/Gelatin Foam Hemostat | Vascular Solutions, Inc. | 2005 | — |
| +2 | K072900 | Excelarrest Foam | Hemostasis, LLC | 2007 | — |
| +1 | K050146 | Vascular Solutions D-Stat Clamp Accessory | Vascular Solutions, Inc. | 2005 | — |
| +1 | K053300 | Syvekexcel | Marine Polymer Technologies, Inc. | 2006 | — |
| +1 | K061219 | D-Stat Dry Hemostatic Bandage | Vascular Solutions, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 7 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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? (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 |
|---|---|---|---|
| * | K012293 | Vascular Solutions Duett Flowable Hemostat | 2002 |
| * | K982818 | Hospal TipstopSummary page 6…s Inc., D-Stat Flowable Hemostat, KO12293; product code MHW, unclassified. 0 TZ Medical Inc., EZ Band; product code MHW class I 0 Gambro Healthcare, Hospal Tipstop, K982818 (cleared for market distribution on October 21, 1998); product code KMF, Unclassified Conclusions: The D-Stat Dry Hemostatic… | 1998 |
| * | — | TZ Medical Inc., EZ Band Named without a submission number |
What descends from it? (44)
See all 448 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050511 | Thrombigel Thrombin/Gelatin Foam Hemostat | 2005 | 25 |
| K050146 | Vascular Solutions D-Stat Clamp Accessory | 2005 | 16 |
| K053300 | Syvekexcel | 2006 | 14 |
| K061219 | D-Stat Dry Hemostatic Bandage | 2006 | 13 |
| K073264 | D-Stat Dry Clear Hemostatic Bandage, Model 3005 | 2007 | 3 |
| K072117 | Thrombix Patch Thrombin Hemostasis Patch | 2007 | 2 |
| K050133 | D-Stat Radial Hemostatic Band | 2005 | 2 |
| K040118 | Vascular Solutions D-Stat Dry Hemostatic Bandage, the D-Stat Radial Hemostatic Band and… | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 15, 2005 | Not classified | Z-0003-06 | Other | package sealing defect - product may not be sterile |
| Sep 9, 2005 | Not classified | Z-0142-06 | Other | A defect affecting the seals of the paper pouch holding the adhesive bandage provided with the D-Stat products was noted during manufacturing. The integrity of the seals of the D-stat Dry pads which are packaged separately in a foil pouch… |
| Sep 9, 2005 | Not classified | Z-0143-06 | Other | A defect affecting the seals of the paper pouch holding the adhesive bandage provided with the D-Stat products was noted during manufacturing. The integrity of the seals of the D-stat Dry pads which are packaged separately in a foil pouch… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K050511 (Vascular Solutions, Inc., 2005) has gone furthest, with 25 descendants of its own.
- 1 other device also cites its predicate K012293.
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 Vascular Solutions D-Stat-Dry Hemostatic Bandage and D-Stat Radial Hemostatic Band is intended for use under the direction of a healthcare professional for the local management and control of bleeding from vascular access sites and percutaneous catheters and tubes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030836 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030836: D-Stat-Dry Hemostatic Bandage; D-Stat Radial 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/K030836
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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