Cleared Traditional

K082013 - CLUE MEDICAL AND CLUE MEDICAL BASIC

K082013 is an FDA 510(k) clearance for CLUE MEDICAL AND CLUE MEDICAL BASIC, manufactured by Telovital GmbH Telemedizin. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K082013 · Telovital GmbH Telemedizin · Cardiovascular device
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Nov 2008
Decision
118d
Days
Class 2
Risk

K082013 is an FDA 510(k) clearance for the CLUE MEDICAL AND CLUE MEDICAL BASIC. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Telovital GmbH Telemedizin (Alexandria, US). The FDA issued a Cleared decision on November 10, 2008 after a review of 118 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.

View all Telovital GmbH Telemedizin devices

FDA 510(k) Submission Details - K082013

510(k) Number K082013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2008
Decision Date November 10, 2008
Days to Decision 118 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 125d · This submission: 118d
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 336
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