# K243495: Natus Ultrapro S100 (982A0594)

- Pathway: 510(k) (Special)
- Applicant: Natus Neurology Incorporated
- Decided: Dec 12, 2024 after 30 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: 8 generations back to K802637 (1980). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130346: Synergy Focus Desktop Version; Synergy Focus Laptop Version, Natus Neurology Incorporated (2013) Summary page 5.
- K162383: Cadwell Sierra Summit, Cadwell Sierra Ascent, Cadwell Industries, Inc. (2017) Summary page 5.

## Most influential descendants
- K243982: Nicolet EDX (2025), 0 descendants of its own

## Indications for use
The UltraPro is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG). Evoked Potentials (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The UltraPro with Natus Elite Software may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The UltraPro with Natus Elite Software is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition. The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System. The UltraPro with Natus Elite Software is intended to be used by a qualified healthcare provider.

Source page: https://510kreport.com/device/K243495
Methodology: https://510kreport.com/methodology