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

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
Combination Product No
PCCP Authorized No
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 17
Devices cleared under the same product code (DRL) and FDA review panel - the closest regulatory comparables to K083347.
UniPulse
K182905 · Seaward Group · Dec 2018
Defibrillator Analyzer Variable Load
K153210 · Bc Group International, Inc. · Dec 2015
DEFIBRILLATOR ANALYZER - DA-2006P
K110192 · Bc Group International, Inc. · Feb 2011
IMPULSE 6000D/7000DP
K072114 · Fluke Biomedical · Jan 2008
PHASE 3, MODEL DT-1
K062099 · Datrend Systems, Inc. · Jan 2007
MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE
K030547 · Guardian Angel Products, Inc. · Jul 2003
K083347 · IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS
Download PDF FDA Summary Fluke Biomedical