Neurology— FDA advisory panel NE
6,090 FDA 510(k) clearances across 183 product codes since 1976.
By Andrew Weston — Installation Systems Engineer
Neurology spans diagnostics and a fast-moving therapeutic edge: EEG systems and electrodes, nerve-conduction and evoked-potential instruments, intracranial pressure monitors, transcranial magnetic stimulators, external nerve stimulators for pain and migraine, and cranial fixation hardware. Like cardiology, the panel's deepest implants — deep-brain stimulation systems, most notably — are PMA devices and invisible in 510(k) data.
What the clearance record captures well is the non-invasive neurotech expansion: external stimulation and neurodiagnostic wearables have broadened the applicant base far beyond the traditional neurodiagnostics manufacturers. It also captures the software edge — quantitative EEG analysis and stroke-triage software clear as neurological devices (though some imaging-based tools file under radiology instead, so searches for "neuro AI" should cover both panels).
Clearances per year
last 10 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
Top product codes in the Neurology panel
all codes- GZJ — STIMPOD NMS460 Nerve Stimulator
- GXY — Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)
- OLO — TMINI Miniature Robotic System
- HAW — Zeta Navigation System
- JXG — Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)
- NUH — TENS 7000 Rechargeable 4 Channel (TENS 7000H)
- GWQ — Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)
- HCG — Target Xtra Detachable Coil
- HCC — A Breathing System (ABS)
- GWF — BraiN20® (BraiN20)
- GZB — Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
- GWM — Pressio 3 Multi-parameter Neuromonitoring System
- GWG — Precision S 4K Sinuscope
- NFO — FACEGYM Pro Device (HD-109)
- GWJ — Integrity V500 (Integrity, Integrity with VEMP)
Recent clearances in the Neurology panel
all clearances- K261024 — TMINI Miniature Robotic System
- K262121 — Ion-L Navigated Instruments
- K253932 — FACEGYM Pro Device (HD-109)
- K261113 — Op.n Spine Navigation and Robotic Guidance
- K253814 — Raney Clips Kit
- K260578 — Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)
- K260880 — SedLine Sedation Monitor
- K261471 — Zeta TMS Navigation System
- K261852 — OTS Hip
- K253767 — UB ERP System
Data sourced from openFDA. This site is unofficial and independent of the FDA.