# K112052: Carefusion Nicolet Edx

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion 209, Inc.
- Decided: Mar 15, 2012 after 241 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922488 (1993). 13 ancestors in all.
30 later devices descend from it; 4 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890495: Nicolet Viking II System, Nicolet Instrument Corp. (1989) Summary page 1.
- K965065: Teca.  Millennium, Medelec, Ltd. (1997) Summary page 1.
- K984052: Synergy Iom System, Oxford Instruments Medical Systems (1999) Summary page 1.
- K991054: Bravo Multi-Modality System, Nicolet Biomedical, Inc. (1999) Summary page 1.
- K102610: Focus Emg Device, Teleemg, LLC USA (2011) Summary page 2.
- K924723: Cadwell Sierra, Cadwell Laboratories, Inc. (1993) Summary page 2.
- K010590: Neuropack Micro, Model Med-9100A Series, Nihon Kohden America, Inc. (2001) Summary page 2.

## Most influential descendants
- K162383: Cadwell Sierra Summit, Cadwell Sierra Ascent (2017), 12 descendants of its own
- K120979: Carefusion Nicolet Edx (2012), 12 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
- K141316: Cognision Eeg/EP System (2015), 7 descendants of its own

## Indications for use
The Care~usion Nicolet EDX is attended for the acquisition- display. analysis. storage. reportng- and mannagement of elecaroplwsiolo-zical information from th# human nervous and muscular systems including Nerve Conduction QNCS%- Electromyozraphy (BMG). Evoked Potentials (EP). Autonomaic Responses and Intra-Operadive Monitoring including Electroencephalographv- (BEG). Evoked Potential (EP') includes Visual Evoked Potentials (VEP). Auditory Evoked Potentials (ABEP), Somatosensorv, Evoked Potentials (SEP), Electroreinogzraphy (ER.G> Electrooculographv (BOG). P300, Motor Evoked Potentials (NFfi). The Nicolet EDX wvith Viking Softare may be used to detenmine autonomic responses to physiologic stimuli by measurngw the change in electrical resistance between two electodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testine also includes assessment of FTR Interval variability. The Nicolet EDX wNith Viking Softwvare is used to detect the physioioaic function of the nervous system, for the location of neural structures during surger)-. and to support the diaynosis of neuromuscular disease or condition- The isted modalities do include overlap in functionality- In general. Nerve Conduction Studies measure the electrial responses of the nerve; Electromyography measures the electracal achavitv of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System. The Nicolet EDX with Viking Softwvare is intended to be used by a qualified healthlcare provider.

Source page: https://510kreport.com/device/K112052
Methodology: https://510kreport.com/methodology