Cleared Traditional

MODEL 633A THREE CHANNEL STRESS TEST (K802190) - FDA 510(k) Clearance

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

K802190 · Quinton, Inc. · Cardiovascular device
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Oct 1980
Decision
43d
Days
Class 2
Risk

K802190 is an FDA 510(k) clearance for the MODEL 633A THREE CHANNEL STRESS TEST. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Quinton, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 43 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Quinton, Inc. devices

Submission Details

510(k) Number K802190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1980
Decision Date October 23, 1980
Days to Decision 43 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
82d faster than avg
Panel avg: 125d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 118
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K802190.
ELECTROCARDIOGRAPH CM3000
K813279 · Philips Medical Systems (Cleveland), Inc. · Dec 1981
STRESS TEST SYSTEM
K810357 · Nihon Kohden America, Inc. · Mar 1981
MODEL 4700A ELECTROCARDIOGRAPH
K802718 · Hewlett-Packard Co. · Nov 1980
ELECTROCARDIOGRAPH, MODEL ECG-5503
K801677 · Nihon Kohden America, Inc. · Aug 1980
ECG MONITOR OSCILLOSCOPE MODEL OEC-3200
K800004 · Nihon Kohden America, Inc. · Mar 1980
ECG MONITOR OSCILLOSCOPE MODEL OEC-3100
K800005 · Nihon Kohden America, Inc. · Mar 1980