# P220023: Paradise® Ultrasound Renal Denervation System

- Pathway: PMA
- Applicant: Recor Medical, Inc.
- Decided: Nov 7, 2023 after 378 days
- Product code: QYI (Ablation Catheter, Renal Denervation)
- Device class: 3
- Recalls of this device: 2 (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. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jan 29, 2026 · Class II · Z-1655-2026: Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
- Jan 29, 2026 · Class II · Z-1654-2026: Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.

Source page: https://510kreport.com/device/P220023
Methodology: https://510kreport.com/methodology