510(k) · Cleared
ClearedVasoStat Hemostasis Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Forge Medical, Inc. · DXC Clamp, Vascular
Cleared on Jan 6, 2016 as substantially equivalent to K123041 (Forge Medical, Inc., 2013) and 1 other predicate after a 57-day review. Its family tree reaches back 5 generations to 1998.
- Decided
- Jan 6, 2016
- Review
- 57 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K984177 (1998). 10 ancestors in all, the oldest K920614 (1992). No later device cites it as a predicate yet.
- Root · 5 generations backK984177 Modification to SkvekpatchMarine Polymer Technologies, Inc. · 1998
- 4 generations backK021062 Chito-SealAbbott Vascular, Inc. · 2002
- 3 generations backK040208 Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-BandTz Medical, Inc. · 2004 · Recalled
- 2 generations backK092503 Radar Vascular Compression DevicesAdvanced Vascular Dynamics · 2009
- 1 generation backK123041 Vasostat Hemostasis DeviceForge Medical, Inc. · 2013
- This deviceK153259 VasoStat Hemostasis DeviceForge Medical, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K984177 | Modification to Skvekpatch | Marine Polymer Technologies, Inc. | 1998 | — |
| −4 | K021062 | Chito-Seal | Abbott Vascular, Inc. | 2002 | — |
| −3 | K040208 | Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-Band | Tz Medical, Inc. | 2004 | 1 |
| −2 | K092503 | Radar Vascular Compression Devices | Advanced Vascular Dynamics | 2009 | — |
| −1 | K123041 | Vasostat Hemostasis Device | Forge Medical, Inc. | 2013 | — |
| 0 (this device) | K153259 | VasoStat Hemostasis Device | Forge Medical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K123041 | Vasostat Hemostasis DeviceSummary page 4…evice Classification Name Vascular clamp Number and 870.4450 Product Code: DXC Predicate Devices: VasoStat™ Hemostasis Device (Forge Medical): K123041 RadAR™ Vascular Compression Assist Devices (Advanced Vascular Dynamics): K142122 Dev… | 2013 |
| * | K142122 | Radar Vascular Compression DeviceSummary page 4…VasoStat™ Hemostasis Device (Forge Medical): K123041 RadAR™ Vascular Compression Assist Devices (Advanced Vascular Dynamics): K142122 Device Description VasoStat™ Hemostasis Device is a device that is adhered to the patient’s skin direct… | 2014 |
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 18 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 10 ancestors has a recall of any class.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 VasoStat™ Hemostasis Device is indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm or lower leg, including radial artery catheterization, pedal or tibial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153259 · printed Nov 3, 2026
Cite this page
510(k) Report. “K153259: VasoStat Hemostasis Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153259
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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