Cleared Traditional

K913484 - ZOLL D-900 DEFIBRILLATOR

K913484 is an FDA 510(k) clearance for ZOLL D-900 DEFIBRILLATOR, manufactured by Zmi Corp.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K913484

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.

LDD Device Classification - Class 2, Special Controls

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 116
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K913484.
MODEL #125 CHILD STIMULATION PADS
K921606 · Cardiotronics, Inc. · May 1992
PEDIATRIC DISPOSABLE EXTERNAL DEFIBRILATION/ECG
K912966 · Physio-Control Corp. · Feb 1992
SHOCK-PATCH ADULT DEFIBRILLATION PADS
K920086 · Cardiotronics, Inc. · Feb 1992
ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION
K914458 · Medical Data Electronics · Dec 1991
TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION
K914971 · Nihon Kohden America, Inc. · Dec 1991
MODEL #100 SHOCK-TRODE CHILD DEFIB PADS
K911455 · Cardiotronics, Inc. · Oct 1991