Cleared Traditional

ZOLL AUTOCLAVABLE INTERNAL HANDLES (K963781) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K963781 · Zoll Medical Corp · Cardiovascular device
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May 1997
Decision
242d
Days
Class 2
Risk

K963781 is an FDA 510(k) clearance for the ZOLL AUTOCLAVABLE INTERNAL HANDLES. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Zoll Medical Corp (Burlington, US). The FDA issued a Cleared decision on May 20, 1997 after a review of 242 days - an extended review cycle.

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 Zoll Medical Corp devices

Submission Details

510(k) Number K963781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received September 20, 1996
Decision Date May 20, 1997
Days to Decision 242 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 125d · This submission: 242d
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 19
Devices cleared under the same product code (LDD) and FDA review panel - the closest regulatory comparables to K963781.
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K971194 · Nihon Kohden America, Inc. · Jul 1997
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K914971 · Nihon Kohden America, Inc. · Dec 1991
MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION
K910754 · Hewlett-Packard Co. · May 1991
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K893403 · Hewlett-Packard Co. · Aug 1989