# PDQ: Neurosurgical Nerve Locator

- Device class: 2; regulation: 21 CFR 874.1820; FDA's rule: 510(k) required
- FDA decisions: 36
- 510(k) review time 2021–2025: median 91 days (middle half 89–183)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2015: 3
- 2016: 3
- 2017: 2
- 2018: 4
- 2019: 4
- 2021: 2
- 2022: 2
- 2023: 1
- 2025: 1
- 2026: 2

## Most-cited predicates
- K171807: ES2 Neuromonitoring Accessory Instruments (2017), cited by 3
- K190163: ALARA Neuro Access Kit (2019), cited by 2
- K143641: NuVasive NVM5 System (2015), cited by 2
- K123307: Nuvasive NVM5 System (2013), cited by 2
- 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), cited by 2
- K152747: DSG Threaded Drill System (2016), cited by 2
- K152942: NuVasiveNVM5 System (2016), cited by 2
- K162313: NuVasive Next Generation NVM5 System (2017), cited by 2
- K181559: Neurosign V4 Intraoperative Nerve Monitor (2018), cited by 1
- K173526: SENTIO MMG Gen 2 (2018), cited by 1

Source page: https://510kreport.com/product-code/PDQ
Data by year (CSV): https://510kreport.com/product-code/PDQ.csv