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)
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.

View all Et Medical Devices Spa devices

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
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 336
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K051534.
ELI 350 ELECTROCARDIOGRAPH
K062677 · Mortara Instrument, Inc. · Nov 2006
PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801
K060766 · Omron Healthcare, Inc. · Jun 2006
CARDIOFAX CE, MODEL ECG-1500 A
K052511 · Nihon Kohden America, Inc. · May 2006
PHILIPS 12-LEAD ALGORITHM
K052049 · Philips Medical Systems · Aug 2005
CARDIOVIT AT-10PLUS
K050686 · Schiller AG · May 2005
12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200
K050074 · Welch Allyn, Inc. · Mar 2005