510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250515Substantially Equivalent

EpiMonitor

EMPATICA S.r.l., Milano, IT / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250515 is the FDA 510(k) clearance record for EpiMonitor, a class II device, cleared for Empatica S.r.l. on under FDA product code POS (Physiological Signal Based Seizure Monitoring System). FDA's definition for product code POS reads: "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...". FDA records list 9 510(k) clearances for Empatica S.r.l., from to . As of , FDA records show no recalls naming K250515.

Clearance record

Decision date
Received
(118 days to decision)
Product code
POS Physiological Signal Based Seizure Monitoring System
Regulation
21 CFR 882.1580
Device class
Class II
Review panel
Neurology
Applicant
Empatica S.r.l. Via Stendhal, 36, Milano, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code POS

Trailing 12 months
1 clearance under product code POS in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code POS, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260