Cleared Traditional

INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS) (K111160) - FDA 510(k) Clearance

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

K111160 · Intricon Datrix Corporation · Cardiovascular device
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Aug 2011
Decision
98d
Days
Class 2
Risk

K111160 is an FDA 510(k) clearance for the INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS). Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Intricon Datrix Corporation (Appollo Beach, US). The FDA issued a Cleared decision on August 1, 2011 after a review of 98 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 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 Intricon Datrix Corporation devices

Submission Details

510(k) Number K111160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2011
Decision Date August 01, 2011
Days to Decision 98 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 125d · This submission: 98d
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 Peers - DSI Detector And Alarm, Arrhythmia

All 397
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