Cleared Traditional

Embrace (K181861) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence.

K181861 · Empatica S.R.L. · Neurology device
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Optimized for regulatory review, auditing and printing
Dec 2018
Decision
161d
Days
Class 2
Risk

K181861 is an FDA 510(k) clearance for the Embrace. Classified as Physiological Signal Based Seizure Monitoring System (product code POS), Class II - Special Controls.

Submitted by Empatica S.R.L. (Milano, IT). The FDA issued a Cleared decision on December 20, 2018 after a review of 161 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1580 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Empatica S.R.L. devices

Submission Details

510(k) Number K181861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2018
Decision Date December 20, 2018
Days to Decision 161 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 148d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code POS Physiological Signal Based Seizure Monitoring System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1580
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Regulatory Consultant

Rakesh Lal
Rakesh Lal

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT03207685 Unknown Interventional Industry-sponsored

Generalized Seizure Detection And Alerting In The EMU With The Empatica Embrace Watch And Smartphone-Based Alert System

Characterizing Generalized Seizure Detection And Alerting In The Epilepsy Monitoring Unit With The Empatica Embrace Watch And Smartphone-Based Alert System

100
Patients (est.)
2
Sites
Supportive_care
Purpose
Open label
Masking
Condition studied Epilepsy
Study design Single group
Eligibility All sexes · 1 Month+
Principal investigator Rosalind W Picard, Sc.D.
Sponsor Empatica, Inc. (industry)
Started 2017-06-30 → Primary completion 2019-01-15 → Completed 2022-01-01
Primary outcome
Comparison of Video-EEG to Embrace System
Secondary outcome
Alarm System Comparison
View full study on ClinicalTrials.gov