Neurology— FDA advisory panel NE
6,121 FDA 510(k) clearances across 184 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
- OLO — Remex Spine Surgery Navigation - Universal Instruments
- GXY — Dexus Prosthetic System (MSL2, MSR2)
- HAW — Geniant Cranial (Navigated Neurosurgical Positioning Robot)
- JXG — Codman® Distal Peritoneal Catheter, Barium Open End (82-1682) +1 more
- NUH — Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J +6 more
- GWQ — Enobio Dx (3 models)
- HCG — MICRUSFRAME (19+ models)
- 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 — PureLift Pro Max
- GWJ — Integrity V500 (Integrity, Integrity with VEMP)
Recent clearances in the Neurology panel
all clearances- K254174 — Surgical Power System
- K254177 — Disposable Sterile Skull Drill (LZ)
- K262861 — PureLift Pro Max
- K262874 — CraniUS Plate
- K253856 — Geniant Cranial (Navigated Neurosurgical Positioning Robot)
- K260396 — KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)
- K261131 — Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J +6 more
- K262235 — ApexCut Blade with Automated EM Tracking (6 models)
- K260387 — SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)
- K262654 — Dexus Prosthetic System (MSL2, MSR2)
Data sourced from openFDA. This site is unofficial and independent of the FDA.