# K190163: ALARA Neuro Access Kit

- Pathway: 510(k) (Traditional)
- Applicant: SurGenTec, LLC
- Decided: Jul 16, 2019 after 166 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: 11 generations back to K950697 (1995). 100 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171807: ES2 Neuromonitoring Accessory Instruments, Stryker Corporation (2017) Summary page 4.

## Most influential descendants
- K240664: ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (2024), 1 descendant of its own
- K243945: ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (2025), 0 descendants of its own

## Indications for use
The ALARA Neuro Access Kit is indicated for pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback.

Source page: https://510kreport.com/device/K190163
Methodology: https://510kreport.com/methodology