Cleared Traditional

K082380 - VICARDIO 12B

K082380 is an FDA 510(k) clearance for VICARDIO 12B, manufactured by Energy-Lab Technologies GmbH. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K082380 · Energy-Lab Technologies GmbH · Cardiovascular device
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Dec 2008
Decision
106d
Days
Class 2
Risk

K082380 is an FDA 510(k) clearance for the VICARDIO 12B. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Energy-Lab Technologies GmbH (Hasbrouck Heights, US). The FDA issued a Cleared decision on December 3, 2008 after a review of 106 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 Energy-Lab Technologies GmbH devices

FDA 510(k) Submission Details - K082380

510(k) Number K082380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2008
Decision Date December 03, 2008
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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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