Cleared Traditional

K903018 - MEDTRONIC ANDOVER MEDICAL SAF-D-FIB MOD...

K903018 is the FDA 510(k) clearance for MEDTRONIC ANDOVER MEDICAL SAF-D-FIB MOD... by Medtronic Andover Medical, Inc.. It is a Class 2 Cardiovascular device (product code LDD) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K903018 · Medtronic Andover Medical, Inc. · Cardiovascular device
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Dec 1990
Decision
145d
Days
Class 2
Risk

K903018 is an FDA 510(k) clearance for the MEDTRONIC ANDOVER MEDICAL SAF-D-FIB MODEL 1220-002. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Medtronic Andover Medical, Inc. (Haverhill, US). The FDA issued a Cleared decision on December 3, 1990 after a review of 145 days - within the typical 510(k) review window.

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. 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 Medtronic Andover Medical, Inc. devices

Submission Details

510(k) Number K903018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1990
Decision Date December 03, 1990
Days to Decision 145 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 125d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDD Dc-defibrillator, Low-energy, (including Paddles)
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.

Regulatory Peers - LDD Dc-defibrillator, Low-energy, (including Paddles)

All 62
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K903018.
SERIES 1500 RESPONDER
K902782 · Marquette Electronics, Inc. · Jan 1991
FIRST MEDIC MODEL 510
K896903 · Spacelabs, Inc. · Dec 1990
LIFEPAK 9 DEFIBRILLATOR & CARDIAC MONITOR/MODIFIED
K905510 · Physio-Control Corp. · Dec 1990
LIFEPAK 300 AUTOMATIC ADVISORY DEFIBRILLATOR
K902478 · Physio-Control Corp. · Oct 1990
THREADED PADDLE PAIRS, INTERNAL ADULT PEDI INFANT
K902590 · Marquette Electronics, Inc. · Jul 1990
LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)
K895379 · Physio-Control Corp. · Feb 1990