# K123255: g.HIamp

- Pathway: 510(k) (Traditional)
- Applicant: G.Tec Medical Engineering GmbH
- Decided: Dec 20, 2012 after 63 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: 3 generations back to K001564 (2000). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060803: G.Usbamp, G.Tec Medical Engineering GmbH (2006) Summary page 1.

## Most influential descendants
- K171669: g.Nautilus PRO (2017), 2 descendants of its own
- K203331: Quick-20m (2021), 1 descendant of its own
- K232210: X-trodes System M (2024), 0 descendants of its own
- K191432: cortiQ PRO (2020), 0 descendants of its own

## Indications for use
The g.Hlamp amplifier is intended to be used to acquire biopotentials and transmit them to a computer via the USB port connection. These biopotentials include for example electroencephalogram (EEG), electromyogram (EMO), electrooculogram (EOG), and electrocardiogram (ECG).

Source page: https://510kreport.com/device/K123255
Methodology: https://510kreport.com/methodology