Cleared Traditional

K013717 - BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY

K013717 is an FDA 510(k) clearance for BRENTWOOD REAL TIME ST AND ARRHYTHMIA A..., manufactured by Brentwood Medical Technology Corp.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K013717 · Brentwood Medical Technology Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
90d
Days
Class 2
Risk

K013717 is an FDA 510(k) clearance for the BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Brentwood Medical Technology Corp. (Torrance, US). The FDA issued a Cleared decision on February 6, 2002 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 870.2340 - 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.

FDA 510(k) Submission Details - K013717

510(k) Number K013717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2001
Decision Date February 06, 2002
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 491
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K013717.
PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES
K020708 · Philips Medical Systems, Inc. · Apr 2002
COSMED QUARK C12/QUARK T12
K014262 · Cosmed Srl · Mar 2002
PRIME ECG SYSTEM
K012414 · Meridian Medical Technologies, Inc. · Mar 2002
CAIRD TECHNOLOGY HOLTER 2000
K012686 · Caird Technology · Dec 2001
CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH
K013367 · Reynolds Medical , Ltd. · Dec 2001
MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
K013564 · Cambridge Heart, Inc. · Nov 2001
K013717 · BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY
Download PDF FDA Summary Brentwood Medical Tec…