Cleared Traditional

K250356 - MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250356 · Infobionic, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
172d
Days
Class 2
Risk

K250356 is an FDA 510(k) clearance for the MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000). 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 July 29, 2025 after a review of 172 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 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 Infobionic, Inc. devices

Submission Details

510(k) Number K250356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2025
Decision Date July 29, 2025
Days to Decision 172 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
47d slower than avg
Panel avg: 125d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K250356.
BodyGuardian Remote Monitoring System (BGRMS v3.0)
K243349 · Boston Scientific Cardiac Diagnostic Technologies, Inc. · Jan 2026
Zio AT® device (A100A1001)
K240177 · iRhythm Technologies, Inc. · Oct 2024
MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
K230265 · Infobionic, Inc. · Oct 2023
SmartCardia 7L Platform
K231276 · Smartcardia SA · Aug 2023