# K253771: Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)

- Pathway: 510(k) (Traditional)
- Applicant: Nanjing Devin Medical Technology Co., Ltd.
- Decided: Mar 2, 2026 after 96 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). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232241: Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018), Betters (Suzhou) Medical Co., Ltd. (2023) Summary page 5.

## Indications for use
The Disposable Microwave Ablation Antenna, used in conjunction with the compatible Microwave Ablation Device, is intended for the coagulation (ablation) of soft tissue. The Disposable Microwave Ablation Antenna is not intended for cardiac use.

Source page: https://510kreport.com/device/K253771
Methodology: https://510kreport.com/methodology