Cleared Traditional

K802368 - OPTION 301 PACEMAKER EVAL. MODULE MAC-1

K802368 is an FDA 510(k) clearance for OPTION 301 PACEMAKER EVAL. MODULE MAC-1, manufactured by Marquette Electronics, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K802368 · Marquette Electronics, Inc. · Cardiovascular device
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Mar 1981
Decision
156d
Days
Class 2
Risk

K802368 is an FDA 510(k) clearance for the OPTION 301 PACEMAKER EVAL. MODULE MAC-1. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Marquette Electronics, Inc. (Walker, US). The FDA issued a Cleared decision on March 4, 1981 after a review of 156 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Marquette Electronics, Inc. devices

FDA 510(k) Submission Details - K802368

510(k) Number K802368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1980
Decision Date March 04, 1981
Days to Decision 156 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
31d slower than avg
Panel avg: 125d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 436
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K802368.
PHYSIOLOGIC RECORDER
K810696 · Honeywell, Inc. · Mar 1981
LIFEPAK 7 ACUTE CARDIAC CARE SYSTEM
K810154 · Physio-Control Corp. · Mar 1981
STRESS TEST SYSTEM
K810357 · Nihon Kohden America, Inc. · Mar 1981
ECG FUNCTION BLOCK
K810176 · Honeywell, Inc. · Feb 1981
MICROPROCESSOR CONTROLLED ELECTROCARDIO
K810263 · Honeywell, Inc. · Feb 1981
ECG ARRHYTHMIA STIMULATOR
K810104 · Belmont Instrument Corp. · Jan 1981