Cleared Special

K070280 - CARDIODAY, VERSION 2.0

K070280 is an FDA 510(k) clearance for CARDIODAY, manufactured by Getemed Medizin- Und Informationstechnik AG. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Special 510(k) pathway after a 25-day FDA review.

K070280 · Getemed Medizin- Und Informationstechnik AG · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
25d
Days
Class 2
Risk

K070280 is an FDA 510(k) clearance for the CARDIODAY, VERSION 2.0. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Getemed Medizin- Und Informationstechnik AG (Great Neck, US). The FDA issued a Cleared decision on February 23, 2007 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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. Low regulatory complexity profile. 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 - K070280

510(k) Number K070280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2007
Decision Date February 23, 2007
Days to Decision 25 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
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 411
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