Cleared Traditional

K083347 - IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS

K083347 is an FDA 510(k) clearance for IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS, manufactured by Fluke Biomedical. The device is a Class 2 Cardiovascular device with product code DRL cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K083347 · Fluke Biomedical · Cardiovascular device
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Dec 2008
Decision
41d
Days
Class 2
Risk

K083347 is an FDA 510(k) clearance for the IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS. Classified as Tester, Defibrillator (product code DRL), Class II - Special Controls.

Submitted by Fluke Biomedical (Orange, US). The FDA issued a Cleared decision on December 24, 2008 after a review of 41 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fluke Biomedical devices

FDA 510(k) Submission Details - K083347

510(k) Number K083347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2008
Decision Date December 24, 2008
Days to Decision 41 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
84d faster than avg
Panel avg: 125d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRL Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DRL Tester, Defibrillator

All 7
Devices cleared under the same product code (DRL) and FDA review panel - the closest regulatory comparables to K083347.
Delta 3300
K190437 · Netech Corporation · Aug 2019
UniPulse
K182905 · Seaward Group · Dec 2018
MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER
K954391 · Bio-Tek Instruments, Inc. · Nov 1995
IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER
K941404 · Hogan & Hartson · Jun 1994
DEFIBRILLATOR ANALYZER MODEL QED-5
K904159 · Bio-Tek Instruments, Inc. · Mar 1991
DEFIBRILLATOR INTERAL PADDLE TEST LOAD
K790394 · Physio-Control Corp. · Mar 1979