# K161893: Neuromonitoring Kit

- Pathway: 510(k) (Traditional)
- Applicant: SI-BONE, Inc.
- Decided: Oct 18, 2016 after 99 days
- Product code: PDQ (Neurosurgical Nerve Locator)
- 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: 5 generations back to K980148 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072736: Rhythmlink International Monopolar Stimulating Instrument, Rhythmlink International, LLC (2008) Summary page 4.

## Indications for use
The Neuromonitoring Kit is indicated for stimulation of peripheral motor nerves, including spinal nerve roots, for localization and identification during surgery.

Source page: https://510kreport.com/device/K161893
Methodology: https://510kreport.com/methodology