510(k) · Cleared
ClearedD-Stat Radial Hemostatic Band
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 18, 2005 as substantially equivalent to K030836 (Vascular Solutions, Inc., 2003) after a 28-day review. Its family tree reaches back 4 generations to 1990. 2 later devices descend from it.
- Decided
- Feb 18, 2005
- Review
- 28 days
- Class
- Class U
- Product code
- QSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K896068 (1990). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- 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 deviceK050133 D-Stat Radial Hemostatic BandVascular Solutions, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK200720 D-Stat Radial Topical HemostatVascular Solutions, LLC · 2020
- Descendant · cites it directly · 0 of its ownK092612 D-Stat Rad-Band, Rad-Band, Models 3501, 3505Vascular Solutions, Inc. · 2009
Most influential descendants
Showing 2 of 2 · See allView 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) | K050133 | D-Stat Radial Hemostatic Band | Vascular Solutions, Inc. | 2005 | — |
| +1 | K200720 | D-Stat Radial Topical Hemostat | Vascular Solutions, LLC | 2020 | — |
| +1 | K092612 | D-Stat Rad-Band, Rad-Band, Models 3501, 3505 | Vascular Solutions, Inc. | 2009 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2020 | 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? (1)
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 5…assessment of new materials. Predicate Devices: Vascular Solutions D-Stat Radial Hemostatic Band (K030836) Vascular Solutions D-Stat Dry Hemostatic Bandage (K030836) Conclusions:… | 2003 |
What descends from it? (2)
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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K200720 (Vascular Solutions, LLC, 2020) has gone furthest, with 0 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 Radial Hemostatic Band is applied topically and is indicated 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/K050133 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050133: D-Stat Radial Hemostatic Band.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050133
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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