# K262086: PreludeSYNC™ Radial Compression Device

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jul 22, 2026 after 30 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K984177 (1998). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162988: PreludeSYNC Radial Compression Device, Merit Medical Systems, Inc. (2017) Summary page 5.

## 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/K262086
Methodology: https://510kreport.com/methodology