# K024316: Nim-PRS

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed, Inc.
- Decided: Jan 6, 2003 after 11 days
- Product code: IKN (Electromyograph, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 890.1375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K934426 (1994). 2 ancestors in all.
31 later devices descend from it; 1 cites it directly.
1 of 34 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982595: NIM4, Xomed, Inc. (1998) Summary page 2.

## Most influential descendants
- K083124: NIM 3.0 (2009), 30 descendants of its own
- K182542: The EPAD 2 System (2019), 9 descendants of its own
- K162313: NuVasive Next Generation NVM5 System (2017), 7 descendants of its own
- K162199: Cascade IOMAX Intraoperative Monitor (2017), 7 descendants of its own
- K212166: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2022), 5 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/K024316
Methodology: https://510kreport.com/methodology