510(k) · Cleared
ClearedVasc Band hemostat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lepu Medical Technology (Beijing) Co., Ltd. · DXC Clamp, Vascular
Cleared on Oct 23, 2014 as substantially equivalent to K111837 (Lepu Medical Technology (Beijing) Co., Ltd., 2011) and 1 other predicate after a 59-day review. Its family tree reaches back 5 generations to 1998. 3 later devices descend from it.
- Decided
- Oct 23, 2014
- Review
- 59 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K984177 (1998). 9 ancestors in all, the oldest K920614 (1992). 3 later devices descend from it, 2 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 backK111837 Radial Artery Compression TourniquetLepu Medical Technology (Beijing) Co., Ltd. · 2011
- This deviceK142359 Vasc Band hemostatLepu Medical Technology (Beijing) Co., Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK162988 PreludeSYNC Radial Compression DeviceMerit Medical Systems, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK262086 PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc. · 2026
- 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 3 of 3 · See all- K162988PreludeSYNC Radial Compression DeviceMerit Medical Systems, Inc. · 2017 · cites it directly1descendant
- K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc. · 2026 · 2 generations on0descendants
- 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 | K111837 | Radial Artery Compression Tourniquet | Lepu Medical Technology (Beijing) Co., Ltd. | 2011 | — |
| 0 (this device) | K142359 | Vasc Band hemostat | Lepu Medical Technology (Beijing) Co., Ltd. | 2014 | — |
| +1 | K162988 | PreludeSYNC Radial Compression Device | Merit Medical Systems, Inc. | 2017 | 1 |
| +2 | K262086 | PreludeSYNC™ Radial Compression Device | Merit Medical Systems, Inc. | 2026 | — |
| +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 | 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 |
|---|---|---|---|
| * | K111837 | Radial Artery Compression TourniquetSummary page 4…Vasc Band Common / Usual Name hemostat Classification Name 870.4450, DXC – Clamp, vascular, Class II Predicate Device(s) K111837 – Radial Artery Compression Tourniquet, Lepu Medical K081740 – HemoBand, Hemoband Corporation D… | 2011 |
| * | K081740 | Hemoband, Models HB-NS and HB-NSXLSummary page 4…870.4450, DXC – Clamp, vascular, Class II Predicate Device(s) K111837 – Radial Artery Compression Tourniquet, Lepu Medical K081740 – HemoBand, Hemoband Corporation Device Description Vasc Band hemostat (Vasc Band) is a compression device that applies mechanic… | 2009 |
What descends from it? (3)
2 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 16 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K162988 (Merit Medical Systems, Inc., 2017) has gone furthest, with 1 descendant 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. 2014, 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 Vasc Band hemostat is a compression device to assist hemostasis of arterial, venous and hemodialysis percutaneous access sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142359: Vasc Band hemostat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142359
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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