# K152769: Fremap Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Ad-Tech Medical Instrument Corporation
- Decided: May 6, 2016 after 224 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- 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 K923056 (1992). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133348: Stim Probe, Spes Medica Srl (2014) Summary page 4.
- K944061: Cueva Cranial Nerve Electrode, Ad-Tech Medical Instrument Corp (1995) Summary page 4.

## Indications for use
The FREMAP Cranial Nerve Electrodes are designed for intraoperative (=< 10 hours) monitoring/recording from and stimulation to the facial nerve or facial nerve root at the CP angle during skull based surgical procedures when connected to the MEE-1000A or MEE-2000 Neural Function Measuring System.

Source page: https://510kreport.com/device/K152769
Methodology: https://510kreport.com/methodology