510(k) · Cleared
ClearedCompressar Supercomfort Disc and Strongarm Supercomfort System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Vascular Dynamics · DXC Clamp, Vascular
Cleared on Jun 1, 2004 after an 84-day review. The FDA summary names its predicate without a number. 17 later devices descend from it.
- Decided
- Jun 1, 2004
- Review
- 84 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 3 citing it directly.
- This deviceK040615 Compressar Supercomfort Disc and Strongarm Supercomfort SystemAdvanced Vascular Dynamics · 2004
- 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 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K040615 | Compressar Supercomfort Disc and Strongarm Supercomfort System | Advanced Vascular Dynamics | 2004 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 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? (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 |
|---|---|---|---|
| * | — | CompressAR Universal System CompressAR Comfort Disc Named without a submission number |
What descends from it? (17)
See all 173 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?
- 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?
This device is indicated for use to provide hemostasis of the femoral vascular access
site during and following catheterization or cannulation procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040615: Compressar Supercomfort Disc and Strongarm Supercomfort System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040615
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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