# K240518: swiftPro™ System

- Pathway: 510(k) (Traditional)
- Applicant: Emblation Limited
- Decided: Apr 23, 2024 after 60 days
- Product code: NEY (System, Ablation, Microwave And Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K870028 (1987). 57 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222388: swiftPro System, Emblation, Ltd. (2023) Summary page 5.

## Most influential descendants
- K250718: swiftPro System (SWF-SPS); Swift System (SWF-SYS) (2025), 0 descendants of its own

## Indications for use
The swiftPro™ System is a surface-based device intended for the coagulation of soft tissue during non-invasive procedures. The swiftPro™ System is not indicated for use in cardiac procedures.

Source page: https://510kreport.com/device/K240518
Methodology: https://510kreport.com/methodology