Cleared Traditional

IMPULSE 6000D/7000DP (K072114) - FDA 510(k) Clearance

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

K072114 · Fluke Biomedical · Cardiovascular device
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Jan 2008
Decision
180d
Days
Class 2
Risk

K072114 is an FDA 510(k) clearance for the IMPULSE 6000D/7000DP. Classified as Tester, Defibrillator (product code DRL), Class II - Special Controls.

Submitted by Fluke Biomedical (Orange, US). The FDA issued a Cleared decision on January 28, 2008 after a review of 180 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5325 - 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 Fluke Biomedical devices

Submission Details

510(k) Number K072114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2007
Decision Date January 28, 2008
Days to Decision 180 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
55d slower than avg
Panel avg: 125d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRL Tester, Defibrillator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5325
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.