# K123843: Neuroepg System

- Pathway: 510(k) (Traditional)
- Applicant: Strohl Medical Technologies
- Decided: Jun 5, 2013 after 174 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 K934426 (1994). 5 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070608: Smartep, Model M010000, Intelligent Hearing Systems (2007) Summary page 1.

## Most influential descendants
- K132616: EPAD (2014), 11 descendants of its own
- K182542: The EPAD 2 System (2019), 9 descendants of its own
- K213849: SafeOp 2: Neural Informatix System (2022), 4 descendants of its own
- K234092: SafeOp 3: Neural Informatix Systeem (2024), 3 descendants of its own
- K182617: ATEC IOM Accessory Instruments (2019), 3 descendants of its own

## Indications for use
The NeuroEPG System is an evoked response testing and diagnostic device that is capable of eliciting, acquiring and measuring auditory and somatosensory evoked potentials. The intended use of the NeuroEPG System is to objectively record evoked responses from patients 18 years of age and older, upon the presentation of sensory stimuli. The product is indicated for use as a diagnostic aid and adjunctive tool in sensory related disorders (i.e., auditory, somatosensory) and in surgical procedures for intraoperative monitoring. The NeuroEPG System is intended to be used by trained personnel in a hospital, clinic, EEG/EP technologist's, surgeon's, or physician's office, operating room, or other appropriate setting. The anatomical sites of contact for auditory evoked potential (AEP) testing are the patient's ear canal (with the contact object being a sound delivery ear bud), and the patient's head and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials). The anatomical sites of contact for somatosensory evoked potential (SEP) testing are the patient's upper/lower limbs (with the contact object being skin-surface electrodes) and the patient's head and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).

Source page: https://510kreport.com/device/K123843
Methodology: https://510kreport.com/methodology