Cleared Traditional

K864504 - Q5000 STRESS TEST MONITOR

K864504 is an FDA 510(k) clearance for Q5000 STRESS TEST MONITOR, manufactured by Quinton, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K864504 · Quinton, Inc. · Cardiovascular device
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Apr 1987
Decision
146d
Days
Class 2
Risk

K864504 is an FDA 510(k) clearance for the Q5000 STRESS TEST MONITOR. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on April 9, 1987 after a review of 146 days - within the typical 510(k) review window.

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 Quinton, Inc. devices

FDA 510(k) Submission Details - K864504

510(k) Number K864504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1986
Decision Date April 09, 1987
Days to Decision 146 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
21d slower than avg
Panel avg: 125d · This submission: 146d
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 429
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K864504.
MODIFIED Q4000 & Q3040 ELECTROCARDIOGRAPH MONITOR
K873584 · Quinton, Inc. · Oct 1987
MODEL 2240 SLAVE SCOPE
K873346 · Marquette Electronics, Inc. · Oct 1987
ACUSON PHYSIOLOGICAL CONTROL MODULE
K871239 · Acuson Computed Sonography · Jun 1987
EK10 ELECTROCARDIOGRAPH
K870880 · Burdick Corp. · Apr 1987
HORIZON 1100 CARDIAC MONITOR
K864843 · Mennen Medical, Inc. · Mar 1987
MODEL 78534C MONITOR/TERMINAL W/OPTIONS A03
K870380 · Hewlett-Packard Co. · Mar 1987