510(k) · Cleared
ClearedVascular Solutions D-Stat Clamp Accessory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, Inc. · DXC Clamp, Vascular
Cleared on May 27, 2005 as substantially equivalent to K040730 (Vascular Solutions, Inc., 2004) and 1 other predicate after a 123-day review. Its family tree reaches back 5 generations to 1995. 16 later devices descend from it.
- Decided
- May 27, 2005
- Review
- 123 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K953781 (1995). 20 ancestors in all, the oldest K896068 (1990). 16 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 4 generations backK980989 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingInnovative Technologies, Ltd. · 1998
- 3 generations backK010933 Seal-on Topical Hempstatic Powder SprayAlltracel Pharma, Ltd. · 2002
- 2 generations backK024107 Femostop Femoral Compression SystemRadi Medical Systems AB · 2002
- 1 generation backK040730 Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc. · 2004
- This deviceK050146 Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005
- Descendant · cites it directly · 14 of its ownK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006
- Descendant · 2 generations on · 13 of its ownK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
- Descendant · 3 generations on · 5 of its ownK090620 Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009
- Descendant · 2 generations on · 5 of its ownK072890 Stasilon FREntegrion, Inc. · 2007
- Descendant · 3 generations on · 4 of its ownK142363 Nustat, Nustat XRBeeken Biomedical · 2015
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K053300SyvekexcelMarine Polymer Technologies, Inc. · 2006 · cites it directly14descendants
- K061219D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006 · 2 generations on13descendants
- K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009 · 3 generations on5descendants
- K072890Stasilon FREntegrion, Inc. · 2007 · 2 generations on5descendants
- K142363Nustat, Nustat XRBeeken Biomedical · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953781 | Innovative Technologies Calcium Alginate Wound Dressings | Innovative Technologies, Ltd. | 1995 | — |
| −4 | K980989 | 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing | Innovative Technologies, Ltd. | 1998 | — |
| −3 | K010933 | Seal-on Topical Hempstatic Powder Spray | Alltracel Pharma, Ltd. | 2002 | — |
| −2 | K024107 | Femostop Femoral Compression System | Radi Medical Systems AB | 2002 | — |
| −1 | K040730 | Vascular Solutions D-Stat Clamp Hemostatic Clamp | Vascular Solutions, Inc. | 2004 | — |
| 0 (this device) | K050146 | Vascular Solutions D-Stat Clamp Accessory | Vascular Solutions, Inc. | 2005 | — |
| +1 | K053300 | Syvekexcel | Marine Polymer Technologies, Inc. | 2006 | — |
| +2 | K061219 | D-Stat Dry Hemostatic Bandage | Vascular Solutions, Inc. | 2006 | — |
| +3 | K090620 | Quikclot Inteventional, Model P/N 182 | Z-Medica Corporation | 2009 | — |
| +2 | K072890 | Stasilon FR | Entegrion, Inc. | 2007 | — |
| +3 | K142363 | Nustat, Nustat XR | Beeken Biomedical | 2015 | — |
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 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 2 | 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 DXC? 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 DXC device
- #1 K262086 PreludeSYNC™ Radial Compression Devicescore 13.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K040730 | Vascular Solutions D-Stat Clamp Hemostatic ClampSummary page 1…biocompatibility assessment of newv materials. Predicate Devices: Vascular Solutions D-Stat Clamp Accessory (K040730) Vascular Solutions D-Stat Dry Hemostatic Bandage (1K030836) Conclusions:… | 2004 |
| * | K030836 | D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageSummary page 1…Devices: Vascular Solutions D-Stat Clamp Accessory (K040730) Vascular Solutions D-Stat Dry Hemostatic Bandage (1K030836) Conclusions: The D-Stat Clamp Accessory is substantially equivalent to the… | 2003 |
What descends from it? (16)
See all 162 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 10 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K053300 (Marine Polymer Technologies, Inc., 2006) has gone furthest, with 14 descendants of its own.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXC
215in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXC
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXC
442in 2025
MAUDE reports naming product code DXC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 52 | 0 | 298 |
| 2008 | 3 | 29 | 2 | 302 |
| 2009 | 4 | 83 | 2 | 539 |
| 2010 | 2 | — | 1 | 600 |
| 2011 | 6 | 51 | 3 | 691 |
| 2012 | 5 | 73 | 0 | 548 |
| 2013 | 14 | 89 | 0 | 920 |
| 2014 | 4 | 157 | 1 | 494 |
| 2015 | 5 | 71 | 0 | 374 |
| 2016 | 3 | 91 | 0 | 494 |
| 2017 | 3 | 90 | 0 | 416 |
| 2018 | 2 | — | 0 | 391 |
| 2019 | 2 | — | 0 | 393 |
| 2020 | 3 | 209 | 0 | 404 |
| 2021 | 6 | 37 | 0 | 371 |
| 2022 | 1 | — | 1 | 273 |
| 2023 | 4 | 215 | 2 | 674 |
| 2024 | 1 | — | 0 | 375 |
| 2025 | 2 | — | 0 | 442 |
| 2026 | 4 | 125 | 0 | — |
What is it indicated for?
The D-Stat Clamp Accessory is indicated for use with the Compressar Universal System (Advanced Vascular Dynamics) and the Femoral Artery Vascular Clamp (Pressure Products) compression devices or as a stand alone device to assist in the control of bleeding following catheterization or cannulation procedures. Following achieving hemostasis the D-Stat Dry Bandage may be detached from the D-Stat Clamp Accessory and left in place for up to 24 hours 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/K050146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050146: Vascular Solutions D-Stat Clamp Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050146
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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