Cleared Abbreviated

K230265 - MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K230265 · Infobionic, Inc. · Cardiovascular device
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Oct 2023
Decision
248d
Days
Class 2
Risk

K230265 is an FDA 510(k) clearance for the MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Infobionic, Inc. (Chelmsford, US). The FDA issued a Cleared decision on October 6, 2023 after a review of 248 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Infobionic, Inc. devices

Submission Details

510(k) Number K230265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2023
Decision Date October 06, 2023
Days to Decision 248 days
Submission Type Abbreviated
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
123d slower than avg
Panel avg: 125d · This submission: 248d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

MethodSense, Inc.
Rita King

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.

Regulatory Peers - DSI Detector And Alarm, Arrhythmia

All 397
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K230265.
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