Cleared Abbreviated

TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM (K100155) - FDA 510(k) Clearance

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

K100155 · Biomedical Systems Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
90d
Days
Class 2
Risk

K100155 is an FDA 510(k) clearance for the TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Biomedical Systems Corp. (St. Louis, US). The FDA issued a Cleared decision on April 20, 2010 after a review of 90 days - within the typical 510(k) review window.

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 Biomedical Systems Corp. devices

Submission Details

510(k) Number K100155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2010
Decision Date April 20, 2010
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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 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 K100155.
BodyGuardian Remote Monitoring System (BGRMS v3.0)
K243349 · Boston Scientific Cardiac Diagnostic Technologies, Inc. · Jan 2026
MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
K250356 · Infobionic, Inc. · Jul 2025
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
Unified Arrhythmia Diagnostic System PocketECG IV
K193104 · Medicalgorithmics S.A. · Apr 2020