# K262515: Kneu Platform (V2)

- Pathway: 510(k) (Traditional)
- Applicant: Kneu Health Digital, Ltd.
- Decided: Aug 20, 2026 after 30 days
- Product code: GYD (Transducer, Tremor)
- Device class: 2
- Regulation: 21 CFR 882.1950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K854030 (1986). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220820: Parky App, H2o Bilisim Yazilim (2022) Summary page 5.
- K250153: Neu Platform, Neuhealth Digital, Ltd. (2025) Summary page 5.

## Indications for use
The Kneu Platform is intended to quantify the kinematics of movement disorder symptoms, including tremor and dyskinesia, in adults (45 years and older) with mild to moderate Parkinson’s disease.

Source page: https://510kreport.com/device/K262515
Methodology: https://510kreport.com/methodology