510(k) · Cleared
ClearedComfortpress Vascular Compression Assist Device
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 Sep 6, 2007 as substantially equivalent to K053398 (Semler Technologies, Inc. Dba, 2006) after a 31-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Sep 6, 2007
- Review
- 31 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053398 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK053398 Compass Compression Assist HandleSemler Technologies, Inc. Dba · 2006
- This deviceK072167 Comfortpress Vascular Compression Assist DeviceAdvanced Vascular Dynamics · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K053398 | Compass Compression Assist Handle | Semler Technologies, Inc. Dba | 2006 | — |
| 0 (this device) | K072167 | Comfortpress Vascular Compression Assist Device | Advanced Vascular Dynamics | 2007 | — |
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 |
|---|---|---|---|
| * | K053398 | Compass Compression Assist HandleSummary page 1…andle Common name - femoral access compression device Classification name - Clamp, Vascular (21 CFR 870.4450 DXC) Predicate device - CompassTM Compression Assist Handle (K053398) This device handle is similar to the Compass handle, but of a different shape. The ComfortPress device provides an alternative… | 2006 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K053398.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
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/K072167 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072167: Comfortpress Vascular Compression Assist Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072167
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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