Cleared Traditional

ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000 (K950856) - FDA 510(k) Clearance

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

K950856 · Zoll Medical Corp · Cardiovascular device
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Dec 1995
Decision
305d
Days
Class 2
Risk

K950856 is an FDA 510(k) clearance for the ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISO.... Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Zoll Medical Corp (Burlington, US). The FDA issued a Cleared decision on December 29, 1995 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5550 - 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. Elevated predicate reliance profile. 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 K950856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1995
Decision Date December 29, 1995
Days to Decision 305 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
180d slower than avg
Panel avg: 125d · This submission: 305d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5550
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 - DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)

Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K950856.
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