# K180290: Natus Brain Monitor Amplifier

- Pathway: 510(k) (Traditional)
- Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
- Decided: Jun 14, 2018 after 133 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K992283 (1999). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143440: Natus Quantum, Natus Medical Incorporated (2015) Summary page 4.
- K111742: Mdrive, Embla Systems (2011) Summary page 4.
- K172711: Comet-PLUS, Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (2017) Summary page 4.

## Most influential descendants
- K193159: NeuroAmp II, NeuroAmp II.5s (2020), 0 descendants of its own

## Recalls of this device
- Jun 18, 2025 · Class II · Z-2138-2025: Natus received two complaints of left side labeling show impedance for right side.

## Indications for use
The Natus Brain Monitor Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks™/SleepWorks™ software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals. The Natus Brain Monitor Amplifier is intended to be used by trained medical professionals, and is designed for use in clinical environments such as hospital rooms, epilepsy monitoring units, intensive care units, and operating rooms. It can be used with patients of all ages, but is not designed for fetal use.

Source page: https://510kreport.com/device/K180290
Methodology: https://510kreport.com/methodology