510(k) · Cleared
ClearedVascular Solutions D-Stat Dry Hemostatic Bandage, the D-Stat Radial Hemostatic Band and the D-Stat 2 Dry Hemostatic
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 Feb 12, 2004 as substantially equivalent to K030836 (Vascular Solutions, Inc., 2003) and 1 other predicate after a 23-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Feb 12, 2004
- Review
- 23 days
- Class
- Class U
- Product code
- QSX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K896068 (1990). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK896068 Tipstop (TM)Gambro-Hospal, Inc. · 1990
- 3 generations backK982818 Hospal TipstopGambro Healthcare · 1998
- 2 generations backK012293 Vascular Solutions Duett Flowable HemostatVascular Solutions, Inc. · 2002
- 1 generation backK030836 D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc. · 2003 · Recalled
- This deviceK040118 Vascular Solutions D-Stat Dry Hemostatic Bandage, the D-Stat Radial…Vascular Solutions, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K896068 | Tipstop (TM) | Gambro-Hospal, Inc. | 1990 | — |
| −3 | K982818 | Hospal Tipstop | Gambro Healthcare | 1998 | — |
| −2 | K012293 | Vascular Solutions Duett Flowable Hemostat | Vascular Solutions, Inc. | 2002 | — |
| −1 | K030836 | D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage | Vascular Solutions, Inc. | 2003 | 3 |
| 0 (this device) | K040118 | Vascular Solutions D-Stat Dry Hemostatic Bandage, the D-Stat Radial Hemostatic… | Vascular Solutions, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K030836 | D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageSummary page 4…mber (if known): .W'O S)t. [(t Device Name: Vascular Solutions D-Stat DryTM Product Family [the D-Stat Dry Hemostatic Bandage, D-Stat Radial Hemostatic Band (K030836) and the D-Stat 2 Dry Hemostatic Bandage (K033709)]. Indications For Use: ....is intended for use under the directio… | 2003 |
| * | K033709 | Vascular Solutions D-Stat 2 Dry Hemostatic BandageSummary page 4…Name: Vascular Solutions D-Stat DryTM Product Family [the D-Stat Dry Hemostatic Bandage, D-Stat Radial Hemostatic Band (K030836) and the D-Stat 2 Dry Hemostatic Bandage (K033709)]. Indications For Use: ....is intended for use under the direction of a healthcare professional for the lo… | 2003 |
| * | — | D-Stat Dry Hemostatic Bandage Named without a submission number |
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 14 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 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?
....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/K040118 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040118: Vascular Solutions D-Stat Dry Hemostatic Bandage, the D-Stat Radial Hemostatic Band and the D-Stat 2 Dry Hemostatic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040118
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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