# K242345: Delphi Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Quantalx Neuroscience
- Decided: Nov 5, 2024 after 90 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K905059 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160280: MagPro R20, Tonica Elektronik A/S (2016) Summary page 5.

## Indications for use
The Delphi Stimulator is intended to be used for stimulation of peripheral nerves for diagnostic purposes.

Source page: https://510kreport.com/device/K242345
Methodology: https://510kreport.com/methodology