Cleared Traditional

K934016 - POWERCHARGER (FDA 510(k) Clearance)

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

K934016 · Zoll Medical Corp · Cardiovascular device
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Oct 1994
Decision
426d
Days
Class 2
Risk

K934016 is an FDA 510(k) clearance for the POWERCHARGER. Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Zoll Medical Corp (Burlington, US). The FDA issued a Cleared decision on October 18, 1994 after a review of 426 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3600 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Zoll Medical Corp devices

Submission Details

510(k) Number K934016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1993
Decision Date October 18, 1994
Days to Decision 426 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
301d slower than avg
Panel avg: 125d · This submission: 426d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTE Pulse-generator, Pacemaker, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3600
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 - DTE Pulse-generator, Pacemaker, External

All 64
Devices cleared under the same product code (DTE) and FDA review panel - the closest regulatory comparables to K934016.
Solo Pace Control
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K201011 · Medtronic, Inc. · May 2020
Medtronic Model 5392 External Pulse Generator (EPG)
K190825 · Medtronic, Inc. · Apr 2019
Lifetech Cardio Model 8301 Temporary Pacemaker
K182839 · Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. · Feb 2019
Medtronic Model 5392 External Pulse Generator (EPG)
K181973 · Medtronic, Inc. · Aug 2018