# K982595: NIM4

- Pathway: 510(k) (Traditional)
- Applicant: Xomed, Inc.
- Decided: Sep 4, 1998 after 39 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: 1 generation back to K934426 (1994). 1 ancestor in all.
39 later devices descend from it; 2 cite it directly.
1 of 41 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934426: Nerve Integrity Monitor-2 (Nim-2 XL), Xomed-Treace, Inc. (1994) Summary page 1.

## Most influential descendants
- K024316: Nim-PRS (2003), 31 descendants of its own
- K083124: NIM 3.0 (2009), 30 descendants of its own
- K070608: Smartep, Model M010000 (2007), 16 descendants of its own
- K123843: Neuroepg System (2013), 12 descendants of its own
- K132616: EPAD (2014), 11 descendants of its own

## Indications for use
This device is indicated for use in surgical procedures for patient-connected intraoperative nerve monitoring, i.e. assisting the surgeon in locating and mapping motor nerves through the use of electromyographic (EMG) signals and electrical stimulus of nerves.

Source page: https://510kreport.com/device/K982595
Methodology: https://510kreport.com/methodology