# K021185: Nervus Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Taugagreining HF
- Decided: Jul 12, 2002 after 88 days
- Product code: OLV (Standard Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 6 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K080217: Component Neuromonitoring System (2008), 14 descendants of its own
- K081551: Twin Neurotrac-Iii (2008), 8 descendants of its own
- K092573: Nihon Kohden QP-160AK Eeg Trend Program (2010), 7 descendants of its own
- K120485: Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT P (2012), 5 descendants of its own
- K173366: NicoletOne (2018), 3 descendants of its own

## Recalls of this device
- Feb 1, 2018 · Class II · Z-2568-2018: Potential to be able to import an ambulatory exam for a patient for which the exam was not started.
- Sep 11, 2007 · Not classified · Z-0126-2008: Display lock-up: VIASYS Healthcare NicoletOne ICU Monitor freezes up during operation when using the digital video option.

## Indications for use
The Nervus Monitor system is intended to record and process EEG signals from third party transducer such as ECG, EMG, Oxygen Saturation or Respiration, from adult to pediatric patients. The Nervus Monitor is intended for use only by medically trained and qualified personnel, within a hospital or medical environment.

Source page: https://510kreport.com/device/K021185
Methodology: https://510kreport.com/methodology