# K212871: Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Galvanize Therapeutics, Inc.
- Decided: Jun 17, 2022 after 281 days
- Product code: OAB (Low Energy Direct Current Thermal Ablation System)
- 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 K942299 (1995). 50 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183385: NanoKnife System, Angiodynamics (2019) Summary page 4.

## Most influential descendants
- K233884: INUMI™ Flex Needle (2024), 1 descendant of its own
- K253826: Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle (2026), 0 descendants of its own

## Indications for use
The Aliya System is indicated for the surgical ablation of soft tissue.

Source page: https://510kreport.com/device/K212871
Methodology: https://510kreport.com/methodology