510(k) · Cleared
ClearedRadar Vascular Compression Devices
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 Nov 19, 2009 as substantially equivalent to K070423 (Terumo Medical Corp., 2007) and 1 other predicate after a 97-day review. Its family tree reaches back 3 generations to 1998. 9 later devices descend from it.
- Decided
- Nov 19, 2009
- Review
- 97 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K984177 (1998). 6 ancestors in all, the oldest K920614 (1992). 9 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK984177 Modification to SkvekpatchMarine Polymer Technologies, Inc. · 1998
- 2 generations backK021062 Chito-SealAbbott Vascular, Inc. · 2002
- 1 generation backK040208 Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-BandTz Medical, Inc. · 2004 · Recalled
- This deviceK092503 Radar Vascular Compression DevicesAdvanced Vascular Dynamics · 2009
- Descendant · cites it directly · 4 of its ownK111837 Radial Artery Compression TourniquetLepu Medical Technology (Beijing) Co., Ltd. · 2011
- Descendant · cites it directly · 3 of its ownK142122 Radar Vascular Compression DeviceAdvanced Vascular Dynamics · 2014
- Descendant · 2 generations on · 3 of its ownK142359 Vasc Band hemostatLepu Medical Technology (Beijing) Co., Ltd. · 2014
- Descendant · 3 generations on · 1 of its ownK162988 PreludeSYNC Radial Compression DeviceMerit Medical Systems, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK151363 Zephyr Vascular Compression DeviceAdvanced Vascular Dynamics · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K111837Radial Artery Compression TourniquetLepu Medical Technology (Beijing) Co., Ltd. · 2011 · cites it directly4descendants
- K142122Radar Vascular Compression DeviceAdvanced Vascular Dynamics · 2014 · cites it directly3descendants
- K142359Vasc Band hemostatLepu Medical Technology (Beijing) Co., Ltd. · 2014 · 2 generations on3descendants
- K162988PreludeSYNC Radial Compression DeviceMerit Medical Systems, Inc. · 2017 · 3 generations on1descendant
- K151363Zephyr Vascular Compression DeviceAdvanced Vascular Dynamics · 2015 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K984177 | Modification to Skvekpatch | Marine Polymer Technologies, Inc. | 1998 | — |
| −2 | K021062 | Chito-Seal | Abbott Vascular, Inc. | 2002 | — |
| −1 | K040208 | Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-Band | Tz Medical, Inc. | 2004 | 1 |
| 0 (this device) | K092503 | Radar Vascular Compression Devices | Advanced Vascular Dynamics | 2009 | — |
| +1 | K111837 | Radial Artery Compression Tourniquet | Lepu Medical Technology (Beijing) Co., Ltd. | 2011 | — |
| +1 | K142122 | Radar Vascular Compression Device | Advanced Vascular Dynamics | 2014 | — |
| +2 | K142359 | Vasc Band hemostat | Lepu Medical Technology (Beijing) Co., Ltd. | 2014 | — |
| +3 | K162988 | PreludeSYNC Radial Compression Device | Merit Medical Systems, Inc. | 2017 | 1 |
| +2 | K151363 | Zephyr Vascular Compression Device | Advanced Vascular Dynamics | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K070423 | TR BandSummary page 1…equivalence comparison: The predicate devices for this submission are the TR Band submitted by Terumo Medical Corp. and cleared for marketing under 510%k) #K070423 and the Comfort-Band submitted by TZ Medical and cleared under 510(k) K040208. Description of the device: The RadA… | 2007 |
| * | K040208 | Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-BandSummary page 1…and submitted by Terumo Medical Corp. and cleared for marketing under 510%k) #K070423 and the Comfort-Band submitted by TZ Medical and cleared under 510(k) K040208. Description of the device: The RadAR Vascular Compression Devices are compression devices used on the arm.… | 2004 |
What descends from it? (9)
3 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 11 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K111837 (Lepu Medical Technology (Beijing) Co., Ltd., 2011) has gone furthest, with 4 descendants of its own.
- 10 other devices also cite its predicate K070423.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 RADAR Vascular Compression Devices are indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm, including radial 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/K092503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092503: Radar Vascular Compression Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092503
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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