# K080217: Component Neuromonitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Moberg Research, Inc.
- Decided: Nov 5, 2008 after 281 days
- Product code: OMA (Amplitude-Integrated 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: 6 generations back to K875179 (1988). 44 ancestors in all.
14 later devices descend from it; 5 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974496: A-2000 Eeg Monitor with Bis, Aspect Medical Systems, Inc. (1998) Summary page 1.
- K991054: Bravo Multi-Modality System, Nicolet Biomedical, Inc. (1999) Summary page 1.
- K033010: BRM2 Brain Monitor, Brainz Instruments, Ltd. (2003) Summary page 1.
- K031149: Olympic CFM 6000, Olympic Medical Corp. (2003) Summary page 1.
- K010728: Harmone-Schwarzer Eeg System, Stellate Systems (2001) Summary page 1.
- K061640: Integra Mobius Multi-Modality Monitoring System, Integra LifeSciences Corporation (2006) Summary page 1.
- K021185: Nervus Monitor, Taugagreining HF (2002) Summary page 1.
- K960170: Electroencephalograph (Eeg), Moberg Medical, Inc. (1996) Summary page 1.
- K983229: Olympic Medical Lectromed Cerebral Function Monitor System, Olympic Medical Corp. (1999) Summary page 1.

## Most influential descendants
- 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
- K213299: Wireless EEG System (2022), 2 descendants of its own
- K200878: Natus NeuroWorks (2020), 1 descendant of its own

## Recalls of this device
- Feb 20, 2023 · Class II · Z-1338-2023: Battery leakage can cause corrosion to the metal enclosure near the electrical interface. Prolonged contact to corrosive materials could cause injury to skin. DOC

## Indications for use
The Component Neuromonitoring System™ is intended to monitor the state of the brain by recording and displaying EEG signals, and can also receive and display a variety of vital signs and other measurements from third-party monitoring devices (such as ICP, ECG, SpO,, and others). It also has the optional capability to record and display patient video. The Component Neuromonitoring System is intended for use by a physician or other qualified medical personnel. It is intended for use on patients of all ages within a hospital or medical environment, including the operating room, intensive care unit, emergency room, and clinical research settings.

Source page: https://510kreport.com/device/K080217
Methodology: https://510kreport.com/methodology