# K250718: swiftPro System (SWF-SPS); Swift System (SWF-SYS)

- Pathway: 510(k) (Traditional)
- Applicant: Emblation Limited
- Decided: Aug 8, 2025 after 151 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: 13 generations back to K870028 (1987). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240518: swiftPro™ System, Emblation Limited (2024) Summary page 5.
- K181941: Swift System, Emblation, Ltd. (2018) Summary page 5.

## Indications for use
The Swift™ System is a surface-based device intended for the coagulation of soft tissue during non-invasive procedures. The Swift™ System is not indicated for use in genital warts or cardiac procedures. Specific Indication: Treatment of Common and Plantar Warts. 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 genital warts or cardiac procedures. Specific Indication: Treatment of Common and Plantar Warts.

Source page: https://510kreport.com/device/K250718
Methodology: https://510kreport.com/methodology