# K213049: STIMPOD NMS450 Nerve Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Xavant Technology (Pty), Ltd.
- Decided: Oct 16, 2022 after 389 days
- Product code: BXN (Stimulator, Nerve, Battery-Powered)
- 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: 5 generations back to K882438 (1988). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102084: Stimpod NMS450 Nerve Stimulator, Xavant Technology (Pty), Ltd. (2010) Summary page 5.

## Indications for use
This device is a nerve stimulation device designed to be used by an anesthetist during: 1. General anesthesia, for the purpose of establishing the efficacy of a Neuromuscular Blocking Agent using non-invasive surface electrodes. 2. Regional anesthesia, for the purpose of: i. nerve mapping using the non-invasive Nerve Mapping Probe (supplied) ii. nerve locating using invasive needles (not supplied)

Source page: https://510kreport.com/device/K213049
Methodology: https://510kreport.com/methodology