510(k) · Cleared
Recalled · Class II · 2017PreludeSYNC Radial Compression Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · DXC Clamp, Vascular
Cleared on Jan 25, 2017 as substantially equivalent to K142359 (Lepu Medical Technology (Beijing) Co., Ltd., 2014) after a 90-day review. Its family tree reaches back 6 generations to 1998. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 25, 2017
- Review
- 90 days
- Class
- Class II
- Product code
- DXC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K984177 (1998). 10 ancestors in all, the oldest K920614 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK984177 Modification to SkvekpatchMarine Polymer Technologies, Inc. · 1998
- 5 generations backK021062 Chito-SealAbbott Vascular, Inc. · 2002
- 4 generations backK040208 Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-BandTz Medical, Inc. · 2004 · Recalled
- 3 generations backK092503 Radar Vascular Compression DevicesAdvanced Vascular Dynamics · 2009
- 2 generations backK111837 Radial Artery Compression TourniquetLepu Medical Technology (Beijing) Co., Ltd. · 2011
- 1 generation backK142359 Vasc Band hemostatLepu Medical Technology (Beijing) Co., Ltd. · 2014
- This deviceK162988 PreludeSYNC Radial Compression DeviceMerit Medical Systems, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK262086 PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K984177 | Modification to Skvekpatch | Marine Polymer Technologies, Inc. | 1998 | — |
| −5 | K021062 | Chito-Seal | Abbott Vascular, Inc. | 2002 | — |
| −4 | K040208 | Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-Band | Tz Medical, Inc. | 2004 | 1 |
| −3 | K092503 | Radar Vascular Compression Devices | Advanced Vascular Dynamics | 2009 | — |
| −2 | K111837 | Radial Artery Compression Tourniquet | Lepu Medical Technology (Beijing) Co., Ltd. | 2011 | — |
| −1 | K142359 | Vasc Band hemostat | Lepu Medical Technology (Beijing) Co., Ltd. | 2014 | — |
| 0 (this device) | K162988 | PreludeSYNC Radial Compression Device | Merit Medical Systems, Inc. | 2017 | — |
| +1 | K262086 | PreludeSYNC™ Radial Compression Device | Merit Medical Systems, Inc. | 2026 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K142359 | Vasc Band hemostatSummary page 4…Trade Name: Vasc™ Band Hemostat Classification Name: Vascular Clamp Predicate Premarket Notification: K142359 Device Manufacturer: Lepu Medical Technology (Beijing) Co., Ltd. This predicate has n… | 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 |
|---|---|---|---|
| K262086 | PreludeSYNC™ Radial Compression Device | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 3, 2017 | Class II | Z-1766-2017 | Process control | Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compression Device because particulate generated during the manufacturing process may enter the valve, preventing a complete seal of the inflation… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K262086 (Merit Medical Systems, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K142359.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 PreludeSYNC is a compression device used to assist in gaining hemostasis of arterial percutaneous access sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162988: PreludeSYNC Radial 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/K162988
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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