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

Top product codes in the Neurology panel

all codes

Recent clearances in the Neurology panel

all clearances

Data sourced from openFDA. This site is unofficial and independent of the FDA.