Cleared Special

K082124 - CARDITTE MICROTEL

K082124 is an FDA 510(k) clearance for CARDITTE MICROTEL, 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 206-day FDA review.

K082124 · Et Medical Devices Spa · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
206d
Days
Class 2
Risk

K082124 is an FDA 510(k) clearance for the CARDITTE MICROTEL. 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 February 19, 2009 after a review of 206 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. 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 - K082124

510(k) Number K082124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2008
Decision Date February 19, 2009
Days to Decision 206 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
81d slower than avg
Panel avg: 125d · This submission: 206d
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 K082124.
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K081437 · Ge Medical Systems Information Technologies · Jul 2008