# K162988: PreludeSYNC Radial Compression Device

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jan 25, 2017 after 90 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K984177 (1998). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142359: Vasc Band hemostat, Lepu Medical Technology (Beijing) Co., Ltd. (2014) Summary page 4.

## Most influential descendants
- K262086: PreludeSYNC™ Radial Compression Device (2026), 0 descendants of its own

## Recalls of this device
- Mar 3, 2017 · Class II · Z-1766-2017: 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, prevent

## Indications for use
The PreludeSYNC is a compression device used to assist in gaining hemostasis of arterial percutaneous access sites.

Source page: https://510kreport.com/device/K162988
Methodology: https://510kreport.com/methodology