# K081551: Twin Neurotrac-Iii

- Pathway: 510(k) (Traditional)
- Applicant: Astro-Med, Inc.
- Decided: Dec 24, 2008 after 204 days
- Product code: OMA (Amplitude-Integrated Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K963644 (1996). 22 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960170: Electroencephalograph (Eeg), Moberg Medical, Inc. (1996) Summary page 1.
- K914571: Neurotrac II, Moberg Medical, Inc. (1992) Summary page 1.
- K021185: Nervus Monitor, Taugagreining HF (2002) Summary page 1.
- K031149: Olympic CFM 6000, Olympic Medical Corp. (2003) Summary page 1.
- K071449: BRM3 Brain Monitor, Brainz Instruments, Ltd. (2007) 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
- K213299: Wireless EEG System (2022), 2 descendants of its own
- K254213: Pascall Sensor Unit (PSU1) (2026), 0 descendants of its own
- K240593: VEEGix EEG System (2024), 0 descendants of its own

## Indications for use
To record the electroencephalogram (EEG) and the computed EEG trends over extended periods of time in order for trained health care professionals to observe changes over time. TWin Neurotrac-lll does not provide any diagnostic conclusion about the patient's condition. TWin-Neurotrac-ill is intencied for use only by medically trained and qualified personnel, within a hospital or medical environment.

Source page: https://510kreport.com/device/K081551
Methodology: https://510kreport.com/methodology