510(k) · Cleared
ClearedZephyr Vascular Compression 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 Jul 31, 2015 as substantially equivalent to K070423 (Terumo Medical Corp., 2007) and 1 other predicate after a 71-day review. Its family tree reaches back 5 generations to 1998. 1 later device descends from it.
- Decided
- Jul 31, 2015
- Review
- 71 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K984177 (1998). 9 ancestors in all, the oldest K920614 (1992). 1 later device descends from it, 1 citing it directly.
- 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 backK142122 Radar Vascular Compression DeviceAdvanced Vascular Dynamics · 2014
- This deviceK151363 Zephyr Vascular Compression DeviceAdvanced Vascular Dynamics · 2015
- Descendant · cites it directly · 0 of its ownK170958 ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in /…Tricol Biomedical, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K170958ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cmTricol Biomedical, Inc. · 2017 · cites it directly0descendants
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 | K142122 | Radar Vascular Compression Device | Advanced Vascular Dynamics | 2014 | — |
| 0 (this device) | K151363 | Zephyr Vascular Compression Device | Advanced Vascular Dynamics | 2015 | — |
| +1 | K170958 | ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm | Tricol Biomedical, Inc. | 2017 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (3)
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 |
|---|---|---|---|
| * | K070423 | TR BandSummary page 4…egally marketed device for substantial equivalence comparison: The predicate devices for this submission are the TR Band from Terumo International Systems (K070423), Vasc Band from Lepu Medical Technologies (K111831), and RadAR Vascular Compression Devices from Advanced Vascular Dynami… | 2007 |
| Kept off the family tree | K111831 | FDA’s K111831 is MX-7000 Microxel Our reading of the summary gave K111831, FDA’s number for MX-7000 Microxel (Bio-Med USA, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Vasc Band”. Kept off the family tree. Summary page 4…omparison: The predicate devices for this submission are the TR Band from Terumo International Systems (K070423), Vasc Band from Lepu Medical Technologies (K111831), and RadAR Vascular Compression Devices from Advanced Vascular Dynamics (K142122). Description of the device: The… | 2011 |
| * | K142122 | Radar Vascular Compression DeviceSummary page 4…nternational Systems (K070423), Vasc Band from Lepu Medical Technologies (K111831), and RadAR Vascular Compression Devices from Advanced Vascular Dynamics (K142122). Description of the device: The Zephyr™ Vascular Compression Devices are external compression devices deployed on… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170958 | ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm | 2017 | 0 |
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 17 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K170958 (Tricol Biomedical, Inc., 2017) has gone furthest, with 0 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. 2015, 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 Zephyr™ 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 or leg, including: radial, brachial,
dorsalis pedis, or tibial blood vessels, arterial or venous line or sheath removal, hemodialysis, and in anticoagulation
therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151363: Zephyr Vascular Compression Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151363
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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