Cleared Traditional

K052898 - IQMARK EZ STRESS

K052898 is an FDA 510(k) clearance for IQMARK EZ STRESS, 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 165-day FDA review.

K052898 · Brentwood Medical Technology Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
165d
Days
Class 2
Risk

K052898 is an FDA 510(k) clearance for the IQMARK EZ STRESS. 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 March 28, 2006 after a review of 165 days - an extended review cycle.

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 - K052898

510(k) Number K052898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2005
Decision Date March 28, 2006
Days to Decision 165 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 125d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Intertek Testing Services
NEIL E DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DPS Electrocardiograph

All 492
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K052898.
CARDIOFAX CE, MODEL ECG-1500 A
K052511 · Nihon Kohden America, Inc. · May 2006
PHYSIOGLOVE ES
K050674 · Commwell , Ltd. · Apr 2006
ATRIA 3100, ATRIA 6100
K060167 · Cardiac Science Corporation · Apr 2006
GALIX ECG PROFESSIONAL STATION
K051163 · Galix Biomedical Instrumentation, Inc. · Jan 2006
CARDIOSOFT PC ECG, USB VERSION
K052295 · Cardiosoft, L.P. · Jan 2006
READMYHEART, MODEL RMH2.0
K052303 · Dailycare Biomedical, Inc. · Dec 2005
K052898 · IQMARK EZ STRESS
Download PDF FDA Summary Brentwood Medical Tec…