# K070608: Smartep, Model M010000

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Hearing Systems
- Decided: Jul 18, 2007 after 135 days
- Product code: GWJ (Stimulator, Auditory, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K934426 (1994). 4 ancestors in all.
16 later devices descend from it; 3 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)
- K904926: Smart-EP, Intelligent Hearing Systems (1991) Summary page 4.
- K890495: Nicolet Viking II System, Nicolet Instrument Corp. (1989) Summary page 4.
- K982595: NIM4, Xomed, Inc. (1998) Summary page 4.

## Most influential descendants
- K123843: Neuroepg System (2013), 12 descendants of its own
- 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

## Indications for use
SmartEP is an evoked response testing and diagnostic device, that is capable of eliciting, acquiring, and measuring auditory, somatosensory, and visual evoked potential data, as well as providing nerve stimulation and monitoring. The intended use of the SmartEP device is to objectively record evoked responses from patients of all ages 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, visual) and in surgical procedures for inter-operative nerve monitoring. The SmartEP system is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's, 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 eartip or headphone, or an ear probe and personal eartip, or earcup) and the patient's scalp 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 and head (with the contact object being two metal prongs or skin-surface electrodes connected to a constant-current stimulator probe) and to the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials). The anatomical sites of contact for visual evoked potential (VEP) testing are the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials). The possible anatomical sites of contact for nerve stimulation and monitoring testing are the patient's nerve tissue (with the contact object being sterile monopolar or bipolar nerve stimulator probe tips), the patient's tympanic membrane and cochlear promontory (with the contact object being a sterile stimulation needle electrode), and the patient's scalp and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).

Source page: https://510kreport.com/device/K070608
Methodology: https://510kreport.com/methodology