# K072964: Nicolet Cortical Stimulator

- Pathway: 510(k) (Abbreviated)
- Applicant: Cardinal Health, Inc.
- Decided: Dec 30, 2008 after 438 days
- Product code: GYC (Electrode, Cortical)
- Device class: 2
- Regulation: 21 CFR 882.1310
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K924226 (1993). 2 ancestors in all.
23 later devices descend from it; 4 cite it directly.
1 of 26 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924226: Ojemann Cortical Stimulator, Radionics, Inc. (1993) Summary page 1.
- K040360: EMU128S, Model EX-NW-128S, Excel Tech., Ltd. (2004) Summary page 1.

## Most influential descendants
- K110410: MS-120BK Electric Stimulator (Extension Unit) (2011), 13 descendants of its own
- K182542: The EPAD 2 System (2019), 9 descendants of its own
- K162199: Cascade IOMAX Intraoperative Monitor (2017), 7 descendants of its own
- K212166: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2022), 5 descendants of its own
- K213849: SafeOp 2: Neural Informatix System (2022), 4 descendants of its own

## Recalls of this device
- Oct 5, 2011 · Not classified · Z-0801-2012: CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annotation label may be inc
- Oct 5, 2011 · Not classified · Z-0799-2012: CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annotation label may be inc
- Oct 5, 2011 · Not classified · Z-0800-2012: CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control Unit. It is possible that during cortical stimulation the electrode annotation label may be inc

## Indications for use
The Cortical Stimulator is intended for use in functional brain mapping procedures during treatment of patients with seizure disorder, providing stimulation via electrode pairs or a hand held bipolar probe.

Source page: https://510kreport.com/device/K072964
Methodology: https://510kreport.com/methodology