# K151600: R-40 EEG  Amplifier

- Pathway: 510(k) (Traditional)
- Applicant: Lifelines, Ltd.
- Decided: Oct 23, 2015 after 133 days
- Product code: GWL (Amplifier, Physiological Signal)
- Device class: 2
- Regulation: 21 CFR 882.1835
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001564 (2000). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103140: Nicolet Wireless Eeg, Carefusion 209, Inc. (2011) Summary page 4.

## Most influential descendants
- K172271: Trackit T4 EEG Amplifier (2018), 0 descendants of its own

## Indications for use
The R-40 EEG Amplifier is intended to be used as a front-end amplifier to acquire, store and transmit electrophysiological signals (wireless or cabled).

Source page: https://510kreport.com/device/K151600
Methodology: https://510kreport.com/methodology