Cleared Traditional

K052295 - CARDIOSOFT PC ECG, USB VERSION

K052295 is an FDA 510(k) clearance for CARDIOSOFT PC ECG, manufactured by Cardiosoft, L.P.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K052295 · Cardiosoft, L.P. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
143d
Days
Class 2
Risk

K052295 is an FDA 510(k) clearance for the CARDIOSOFT PC ECG, USB VERSION. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Cardiosoft, L.P. (Houston, US). The FDA issued a Cleared decision on January 13, 2006 after a review of 143 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 - K052295

510(k) Number K052295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2005
Decision Date January 13, 2006
Days to Decision 143 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
18d slower than avg
Panel avg: 125d · This submission: 143d
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 539
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K052295.
ATRIA 3100, ATRIA 6100
K060167 · Cardiac Science Corporation · Apr 2006
IQMARK EZ STRESS
K052898 · Brentwood Medical Technology Corp. · Mar 2006
GALIX ECG PROFESSIONAL STATION
K051163 · Galix Biomedical Instrumentation, Inc. · Jan 2006
READMYHEART, MODEL RMH2.0
K052303 · Dailycare Biomedical, Inc. · Dec 2005
DATRIX CARDIO WIFI ELECTROCARDIOGRAPH
K053083 · Datrix · Nov 2005
CARDIOLINE AR 600, AR 1200, AR 2100
K051534 · Et Medical Devices Spa · Oct 2005
K052295 · CARDIOSOFT PC ECG, USB VERSION
Download PDF FDA Summary Cardiosoft, L.P.