# K200759: NIM Vital, Nerve Integrity Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed, Inc.
- Decided: Oct 28, 2020 after 218 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K980148 (1998). 16 ancestors in all.
No later device cites it as a predicate yet.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083124: NIM 3.0, Medtronic Xomed, Inc. (2009) Summary page 4.

## Recalls of this device
- Mar 10, 2025 · Class II · Z-1623-2025: Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and medical interv
- Jun 24, 2024 · Class I · Z-2409-2024: Potential for false negative response on the NIM Vital Nerve Monitoring System
- May 3, 2022 · Class II · Z-1224-2022: Software anomaly was identified.
- May 3, 2022 · Class II · Z-1223-2022: Software anomaly was identified.

## Indications for use
The NIM Vital™ System is intended for locating and monitoring, including stimulation, of cranial, spinal, peripheral motor and mixed motor-sensory nerves and registering EMG responses during surgery. The NIM Vital™ System may be used for EMG monitoring in support of surgical procedures including: Intracranial, Extracranial, Intratemporal, Extratemporal and surgeries associated with the Neck, Spine, Thorax, and Upper and Lower Extremities. The NIM Vital™ System is contraindicated for use with paralyzing anesthetic agents that will significantly reduce, if not completely eliminate, EMG responses to direct or passive nerve stimulation.

Source page: https://510kreport.com/device/K200759
Methodology: https://510kreport.com/methodology