# K030526: Pediguard Nerve Detector System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Vision, Inc.
- Decided: Dec 29, 2004 after 679 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K921979 (1993). 6 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980148: Neurosign 800, 8 Channel Motor Nerve Monitor, The Magstim Company, Ltd. (1998) Summary page 1.
- K002677: Nuvasive Ins-1 Intraoperative Nerve Surveillance System, Nuvasive, Inc. (2000) Summary page 1.
- K022020: Justwo Model Tme-601 Root Apex Locator, Toei Electric Co., Ltd. (2002) Summary page 1.

## Most influential descendants
- K123390: Pediguard Nerve Detector System (2013), 5 descendants of its own
- K143159: Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS (2015), 4 descendants of its own
- K152747: DSG Threaded Drill System (2016), 3 descendants of its own
- K162884: SpineGuard DSG Zavation Screw System (2017), 2 descendants of its own
- K201454: DSG Connect Technology (2021), 1 descendant of its own

## Indications for use
The PediGuard is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The PediGuard also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves.

Source page: https://510kreport.com/device/K030526
Methodology: https://510kreport.com/methodology