510(k) · Cleared
ClearedVascular Solutions D-Stat Clamp Hemostatic Clamp
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 Jun 18, 2004 as substantially equivalent to K002767 (Semler Technologies, Inc., 2000) and 3 other predicates after an 88-day review. Its family tree reaches back 4 generations to 1995. 17 later devices descend from it.
- Decided
- Jun 18, 2004
- Review
- 88 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K953781 (1995). 14 ancestors in all, the oldest K920796 (1992). 17 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 3 generations backK980989 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingInnovative Technologies, Ltd. · 1998
- 2 generations backK010933 Seal-on Topical Hempstatic Powder SprayAlltracel Pharma, Ltd. · 2002
- 1 generation backK024107 Femostop Femoral Compression SystemRadi Medical Systems AB · 2002
- This deviceK040730 Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc. · 2004
- Descendant · cites it directly · 16 of its ownK050146 Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005
- Descendant · 2 generations on · 14 of its ownK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006
- Descendant · 3 generations on · 13 of its ownK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
- Descendant · 4 generations on · 5 of its ownK090620 Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009
- Descendant · 3 generations on · 5 of its ownK072890 Stasilon FREntegrion, Inc. · 2007
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K050146Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005 · cites it directly16descendants
- K053300SyvekexcelMarine Polymer Technologies, Inc. · 2006 · 2 generations on14descendants
- K061219D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006 · 3 generations on13descendants
- K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation · 2009 · 4 generations on5descendants
- K072890Stasilon FREntegrion, Inc. · 2007 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953781 | Innovative Technologies Calcium Alginate Wound Dressings | Innovative Technologies, Ltd. | 1995 | — |
| −3 | K980989 | 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing | Innovative Technologies, Ltd. | 1998 | — |
| −2 | K010933 | Seal-on Topical Hempstatic Powder Spray | Alltracel Pharma, Ltd. | 2002 | — |
| −1 | K024107 | Femostop Femoral Compression System | Radi Medical Systems AB | 2002 | — |
| 0 (this device) | K040730 | Vascular Solutions D-Stat Clamp Hemostatic Clamp | Vascular Solutions, Inc. | 2004 | — |
| +1 | K050146 | Vascular Solutions D-Stat Clamp Accessory | Vascular Solutions, Inc. | 2005 | — |
| +2 | K053300 | Syvekexcel | Marine Polymer Technologies, Inc. | 2006 | — |
| +3 | K061219 | D-Stat Dry Hemostatic Bandage | Vascular Solutions, Inc. | 2006 | — |
| +4 | K090620 | Quikclot Inteventional, Model P/N 182 | Z-Medica Corporation | 2009 | — |
| +3 | K072890 | Stasilon FR | Entegrion, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K030836 | FDA’s K030836 is D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic Bandage Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2003 |
| * | K002767 | Compressar Femoral Access Compression DeviceSummary page 2…en conducted. 5 10(k) Summary of Safety and Effectiveness K040730 Page 2 Predicate Devices: lD-Stat Drv I lem(rostatic Bandage (K<130)836) ComprcssAR (K002767) Femoral Artery Vascular (lamp (K964662 and K973216) Ftemostop Compression System (K024107) Conclusions: The D-Stat Clamp is sim… | 2000 |
| * | K964662 | Favc: Femoral Artery Vascular Clamp - Model Number RMDS 1000-15, RMDS 1000-20, RMDS…Summary page 2…mmary of Safety and Effectiveness K040730 Page 2 Predicate Devices: lD-Stat Drv I lem(rostatic Bandage (K<130)836) ComprcssAR (K002767) Femoral Artery Vascular (lamp (K964662 and K973216) Ftemostop Compression System (K024107) Conclusions: The D-Stat Clamp is similar in design and function to the curre… | 1997 |
| * | K973216 | Favc-HH: Femoral Artery Vascular Clamp-Hand Held: 1/2 & 3 Pounds (RMDS810T/815T/820T)Summary page 2…ety and Effectiveness K040730 Page 2 Predicate Devices: lD-Stat Drv I lem(rostatic Bandage (K<130)836) ComprcssAR (K002767) Femoral Artery Vascular (lamp (K964662 and K973216) Ftemostop Compression System (K024107) Conclusions: The D-Stat Clamp is similar in design and function to the currently markete… | 1997 |
| * | K024107 | Femostop Femoral Compression SystemSummary page 2…Predicate Devices: lD-Stat Drv I lem(rostatic Bandage (K<130)836) ComprcssAR (K002767) Femoral Artery Vascular (lamp (K964662 and K973216) Ftemostop Compression System (K024107) Conclusions: The D-Stat Clamp is similar in design and function to the currently marketed D-Stat Dry Hemostatic Bandage, perfor… | 2002 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050146 | Vascular Solutions D-Stat Clamp Accessory | 2005 | 16 |
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 9 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K050146 (Vascular Solutions, Inc., 2005) has gone furthest, with 16 descendants of its own.
- 1 other device also cites its predicate K002767.
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 standalone device to assist in the control of bleeding following catheterization or cannulation procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040730 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040730: Vascular Solutions D-Stat Clamp Hemostatic Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040730
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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