# K162048: EZstim*III Peripheral Nerve Stimulator/Nerve Locator

- Pathway: 510(k) (Traditional)
- Applicant: Halyard Health - Irvine
- Decided: Dec 5, 2016 after 133 days
- Product code: KOI (Stimulator, Nerve, Peripheral, Electric)
- Device class: 2
- Regulation: 21 CFR 868.2775
- 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 K954505 (1996). 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)
- K954505: EZ Stim, Life-Tech Intl., Inc. (1996) Summary page 4.

## Indications for use
The EZstim*III is a battery powered Peripheral Nerve Stimulator/Nerve Locator with two (2) indications for use: (1) on the high (0.05 - 80 mA) output current range, the device is used to monitor the effects of skeletal muscle relaxants during general anesthesia. (2) on the low (0.05-5.0 mA) output current range, it is used as a Nerve Locator to help locate the tip of a hypodermic needle near the nerve to which local anesthesia is to be delivered in Regional Nerve Block procedures.

Source page: https://510kreport.com/device/K162048
Methodology: https://510kreport.com/methodology