Cleared Traditional

K913484 - ZOLL D-900 DEFIBRILLATOR

K913484 is the FDA 510(k) clearance for ZOLL D-900 DEFIBRILLATOR by Zmi Corp.. It is a Class 2 Cardiovascular device (product code LDD) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K913484 · Zmi Corp. · Cardiovascular device
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Dec 1991
Decision
132d
Days
Class 2
Risk

K913484 is an FDA 510(k) clearance for the ZOLL D-900 DEFIBRILLATOR. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Zmi Corp. (Woburn, US). The FDA issued a Cleared decision on December 16, 1991 after a review of 132 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 Zmi Corp. devices

Submission Details

510(k) Number K913484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1991
Decision Date December 16, 1991
Days to Decision 132 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 125d · This submission: 132d
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 K913484.
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K914971 · Nihon Kohden America, Inc. · Dec 1991
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K911662 · Marquette Electronics, Inc. · Oct 1991
12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON
K910144 · Physio-Control Corp. · Jul 1991