# K103140: Nicolet Wireless Eeg

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion 209, Inc.
- Decided: Apr 8, 2011 after 165 days
- Product code: GWL (Amplifier, Physiological Signal)
- Device class: 2
- Regulation: 21 CFR 882.1835
- 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: 4 generations back to K001564 (2000). 13 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061908: Nicoletone System V32 Amplifier, Viasys Neuro Care (2006) Summary page 1.
- K090957: Blackrock Neuroport Biopotential Signal Processing System, I2s Micro Implantable Systems, LLC (2009) Summary page 1.
- K060523: Neuroport Neural Signal Processing System, Cyberkinetics, Inc. (2006) Summary page 1.
- K060803: G.Usbamp, G.Tec Medical Engineering GmbH (2006) Summary page 1.
- K040113: Sandman SD20 Amplifier, Eb Neuro S.P.A. (2004) Summary page 1.
- K033475: Wireless Input Unit, Model Wee-1000A Series, Nihon Kohden America, Inc. (2004) Summary page 2.
- K003175: Compumedics Siesta System, Compumedics Limited (2000) Summary page 1.

## Most influential descendants
- K170441: ElectroTek (2017), 1 descendant of its own
- K162681: Enobio Wireless EEG (2017), 1 descendant of its own
- K151600: R-40 EEG  Amplifier (2015), 1 descendant of its own
- K261604: Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) (2026), 0 descendants of its own
- K212788: Seer Home (2022), 0 descendants of its own

## Recalls of this device
- Feb 27, 2013 · Class II · Z-0946-2013: Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overheating may result in di

## Indications for use
The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit efectrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system.

Source page: https://510kreport.com/device/K103140
Methodology: https://510kreport.com/methodology