# K181941: Swift System

- Pathway: 510(k) (Traditional)
- Applicant: Emblation, Ltd.
- Decided: Oct 18, 2018 after 90 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: 10 generations back to K870028 (1987). 55 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K072870: Microwave Tissue Coagulation System (MTCS), Foundry Newco X, Inc. (2008) Summary page 4.
- K082819: Dermatologic Treatment System (DTS) G2, Miramar Labs, Inc. (2009) Summary page 4.
- K133821: Emprint Ablation System, Covidien, LLC (2014) Summary page 4.

## Most influential descendants
- K222388: swiftPro System (2023), 2 descendants of its own
- K240518: swiftPro™ System (2024), 1 descendant of its own
- K250718: swiftPro System (SWF-SPS); Swift System (SWF-SYS) (2025), 0 descendants of its own

## 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 cardiac procedures.

Source page: https://510kreport.com/device/K181941
Methodology: https://510kreport.com/methodology