# K152547: DNAP Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Ad-Tech Medical Instrument Corporation
- Decided: Mar 4, 2016 after 178 days
- Product code: GZL (Electrode, Depth)
- Device class: 2
- Regulation: 21 CFR 882.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944061 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

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

## Indications for use
The DNAP Cranial Nerve Electrodes are designed for intraoperative monitoring/recording for less than or equal to 10 hours from the cochlear cranial nerves during skull based surgical procedures when connected to the MEE-1000A or MEE-2000 Neural Function Measuring System.

Source page: https://510kreport.com/device/K152547
Methodology: https://510kreport.com/methodology