Cleared Abbreviated

K053263 - CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003

K053263 is an FDA 510(k) clearance for CARDIONET AMBULATORY ECG MONITOR WITH A..., manufactured by Cardionet, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Abbreviated 510(k) pathway after a 154-day FDA review.

K053263 · Cardionet, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
154d
Days
Class 2
Risk

K053263 is an FDA 510(k) clearance for the CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Cardionet, Inc. (San Diego, US). The FDA issued a Cleared decision on April 25, 2006 after a review of 154 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 Cardionet, Inc. devices

FDA 510(k) Submission Details - K053263

510(k) Number K053263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2005
Decision Date April 25, 2006
Days to Decision 154 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
29d slower than avg
Panel avg: 125d · This submission: 154d
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
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K053263.
NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX
K071805 · Datascope Corp. · Sep 2007
MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER
K062976 · Ge Medical Systems Information Technologies · Mar 2007
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0
K070260 · Philips Medical Systems · Feb 2007
VITALOGIK
K052288 · Mennen Medical , Ltd. · Dec 2005
ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.)
K052160 · Welch Allyn, Inc. · Dec 2005
LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P
K050919 · Analogic Corp. · Jun 2005