Cleared Traditional

K963781 - ZOLL AUTOCLAVABLE INTERNAL HANDLES

K963781 is an FDA 510(k) clearance for ZOLL AUTOCLAVABLE INTERNAL HANDLES, manufactured by Zoll Medical Corp. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 242-day FDA review.

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

FDA 510(k) Submission Details - K963781

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
Combination Product No
PCCP Authorized No
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.

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 115
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