Cleared Traditional

HIGHPAK-12 (K062331) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K062331 · Ad Elektronik GmbH · Cardiovascular device
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Jul 2007
Decision
334d
Days
Class 2
Risk

K062331 is an FDA 510(k) clearance for the HIGHPAK-12. Classified as Auxiliary Power Supply (ac Or Dc) For Low-energy Dc-defibrillator (product code MPD), Class II - Special Controls.

Submitted by Ad Elektronik GmbH (Lutsen, US). The FDA issued a Cleared decision on July 10, 2007 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5300 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K062331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2006
Decision Date July 10, 2007
Days to Decision 334 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
209d slower than avg
Panel avg: 125d · This submission: 334d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MPD Auxiliary Power Supply (ac Or Dc) For Low-energy Dc-defibrillator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5300
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.