# K180723: PreludeSYNC DISTAL Radial Compression System

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Apr 17, 2018 after 29 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Mar 11, 2020 · Class II · Z-1796-2020: During the sterilization of radial compression devices, some of the inflatable balloons may break or burst, which may result in air leakage and the inability to maintain pressure/compression. This may

Source page: https://510kreport.com/device/K180723
Methodology: https://510kreport.com/methodology