Cleared Traditional

K760854 - THREE-CHANNEL STRESS TEST SYSTEM (M633)

K760854 is the FDA 510(k) clearance for THREE-CHANNEL STRESS TEST SYSTEM (M633) by Quinton, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K760854 · Quinton, Inc. · Cardiovascular device
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Nov 1976
Decision
28d
Days
Class 2
Risk

K760854 is an FDA 510(k) clearance for the THREE-CHANNEL STRESS TEST SYSTEM (M633). Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Quinton, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1976 after a review of 28 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 K760854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1976
Decision Date November 12, 1976
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
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 265
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K760854.
ELECTROCARDIOGRAPH, EK-7 (3-CHANNELS)
K760271 · Burdick Corp. · Nov 1976
ELECTROCARDIOGRAPH EK-6 W/OPTIONAL CIRC.
K760268 · Burdick Corp. · Nov 1976
CIRCUIT, PRINTED, SERVO-MECHANISM
K760272 · Burdick Corp. · Nov 1976
MONITOR, ELECTROCARDIOSCOPE
K760266 · Burdick Corp. · Oct 1976
LIFEPAK 5 CARDIOSCOPE MODULE (NPN 5)
K760677 · Physio-Control Corp. · Oct 1976
SPACELABS SERIES 1000
K760612 · Spacelabs, Inc. · Sep 1976