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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 513
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K082013.
VICOR PD2I ANALYZER, VERSION 2.1
K082709 · Vicor Technologies, Inc. · Dec 2008
MORTARA ELI 350 ELECTROCARDIOGRAPH
K082946 · Mortara Instrument, Inc. · Dec 2008
VICARDIO 12B
K082380 · Energy-Lab Technologies GmbH · Dec 2008
HANDHELD ECG MONITOR, MODEL MD100
K080933 · Beijing Choice Electronic Technololgy Co., Ltd. · Sep 2008
PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM)
K082312 · Heartscape Technologies, Ltd. · Sep 2008
Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S
K082173 · Cardiac Science Corporation · Aug 2008
K082013 · CLUE MEDICAL AND CLUE MEDICAL BASIC
Download PDF FDA Summary Telovital GmbH Teleme…