Cleared Traditional

K950856 - ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000

K950856 is an FDA 510(k) clearance for ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRIL..., manufactured by Zoll Medical Corp. The device is a Class 2 Cardiovascular device with product code DRO cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K950856 · Zoll Medical Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K950856

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
Combination Product No
PCCP Authorized No
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.

DRO Device Classification - Class 2, Special Controls

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)

All 56
Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K950856.
CARDIOSERV P
K962547 · Marquette Electronics, Inc. · Mar 1997
RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM
K963120 · Marquette Electronics, Inc. · Feb 1997
ESORT II + 400 SERIES MONITOR
K961138 · Medical Data Electronics · Dec 1996
LIFEPAK 11
K951593 · Physio-Control Corp. · Dec 1995
HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR
K950483 · Hewlett-Packard Co. · May 1995
K-DEFIB/PACE CARBON ELECTRODE
K926175 · Katecho, Inc. · Apr 1993