# K944061: Cueva Cranial Nerve Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Ad-Tech Medical Instrument Corp
- Decided: Jan 20, 1995 after 154 days
- Product code: GZL (Electrode, Depth)
- Device class: 2
- Regulation: 21 CFR 882.1330
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K230853: EARP Nerve Cuff Electrode (2023), 1 descendant of its own
- K241917: EARP Nerve Cuff Electrode (2024), 0 descendants of its own
- K152769: Fremap Electrode (2016), 0 descendants of its own
- K152547: DNAP Electrode (2016), 0 descendants of its own

## Recalls of this device
- Oct 8, 2014 · Class II · Z-0106-2015: The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve. .

Source page: https://510kreport.com/device/K944061
Methodology: https://510kreport.com/methodology