DeviceClearance

Product code POS— Neurology

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Classification name
Physiological Signal Based Seizure Monitoring System
Device class
Class 2
Regulation
21 CFR 882.1580
Advisory panel
Neurology
Total cleared
10
First cleared
Most recent

FDA classification definition

“The Physiological signal based seizure monitoring system is a prescription device that uses physiological signal to identify abnormal physiological activity that may be associated with a seizure. The System does not predict seizure onsets, and is not intended as a standalone seizure monitoring device.”

— U.S. Food and Drug Administration, device classification record for product code POS under 21 CFR 882.1580, via openFDA

Market context for product code POS

FDA has cleared 10 devices under product code POS between 2017 and 2025, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code POS

Recent clearances under product code POS

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