Cleared Abbreviated

K100155 - TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM

K100155 is an FDA 510(k) clearance for TRUVUE WIRELESS AMBULATORY ECG MONITORI..., manufactured by Biomedical Systems Corp.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K100155

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.

DSI Device Classification - Class 2, Special Controls

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 275
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