Cleared Traditional

K230457 - Empatica Health Monitoring Platform (FDA 510(k) Clearance)

Also includes:
EmbracePlus Empatica Care Care Portal

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

K230457 · Empatica S.R.L. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
251d
Days
Class 2
Risk

K230457 is an FDA 510(k) clearance for the Empatica Health Monitoring Platform. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Empatica S.R.L. (Milan, IT). The FDA issued a Cleared decision on October 30, 2023 after a review of 251 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Empatica S.R.L. devices

Submission Details

510(k) Number K230457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2023
Decision Date October 30, 2023
Days to Decision 251 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 125d · This submission: 251d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

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