Cleared Special

K051534 - CARDIOLINE AR 600, AR 1200, AR 2100

K051534 is an FDA 510(k) clearance for CARDIOLINE AR 600, manufactured by Et Medical Devices Spa. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Special 510(k) pathway after a 117-day FDA review.

K051534 · Et Medical Devices Spa · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
117d
Days
Class 2
Risk

K051534 is an FDA 510(k) clearance for the CARDIOLINE AR 600, AR 1200, AR 2100. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Et Medical Devices Spa (Cavareno, IT). The FDA issued a Cleared decision on October 5, 2005 after a review of 117 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K051534

510(k) Number K051534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2005
Decision Date October 05, 2005
Days to Decision 117 days
Submission Type Special
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
8d faster than avg
Panel avg: 125d · This submission: 117d
Pathway characteristics
Modification to existing cleared device.

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 513
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K051534.
CARDIOSOFT PC ECG, USB VERSION
K052295 · Cardiosoft, L.P. · Jan 2006
READMYHEART, MODEL RMH2.0
K052303 · Dailycare Biomedical, Inc. · Dec 2005
DATRIX CARDIO WIFI ELECTROCARDIOGRAPH
K053083 · Datrix · Nov 2005
PHILIPS 12-LEAD ALGORITHM
K052049 · Philips Medical Systems · Aug 2005
READMYHEART, MODEL RMH3.0
K050620 · Dailycare Biomedical, Inc. · Jul 2005
ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM
K050858 · Heartlab, Inc. · Jun 2005
K051534 · CARDIOLINE AR 600, AR 1200, AR 2100
Download PDF FDA Summary Et Medical Devices Spa