# K110138: Paired Hydrogel Electrode

- Pathway: 510(k) (Special)
- Applicant: Neurovision Medical Products, Inc.
- Decided: Apr 8, 2011 after 80 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: 3 generations back to K011564 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092744: Neonatal Ecg Electrode, M203KEN, R & D Medical Products, Inc. (2009) Summary page 1.
- K902080: Red Dot 2269 Infant Monitoring Electrode, 3M Company (1990) Summary page 1.
- K954601: Nerve Locator/Monitor System Modification, Rln Systems, Inc. (1995) Summary page 1.

## Indications for use
The Paired Hydrogel Electrode is used for evoked electrophysiological monitoring in soft tissue surgeries were motor nerves are at risk.

Source page: https://510kreport.com/device/K110138
Methodology: https://510kreport.com/methodology