Cleared Traditional

MODIFIED Q4000 & Q3040 ELECTROCARDIOGRAPH MONITOR (K873584) - FDA 510(k) Clearance

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

K873584 · Quinton, Inc. · Cardiovascular device

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Oct 1987

Decision

52d

Days

Class 2

Risk

K873584 is an FDA 510(k) clearance for the MODIFIED Q4000 & Q3040 ELECTROCARDIOGRAPH MONITOR. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on October 26, 1987 after a review of 52 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	K873584 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 04, 1987
Decision Date	October 26, 1987
Days to Decision	52 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

73d faster than avg

Panel avg: 125d · This submission: 52d

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 K873584.

EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER)

K883402 · Quinton, Inc. · Jan 1989

Q5000 ST/HR SLOPE MODIFICATION

K883468 · Quinton, Inc. · Dec 1988

OEC-7102 ECG/NIBP MONITOR

K882254 · Nihon Kohden America, Inc. · Nov 1988

Q5000 STRESS TEST MONITOR

K864504 · Quinton, Inc. · Apr 1987

MODEL 78534C MONITOR/TERMINAL W/OPTIONS A03

K870380 · Hewlett-Packard Co. · Mar 1987

Q700 ELECTROCARDIOGRAPH

K864700 · Quinton, Inc. · Feb 1987

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K873584

Quinton, Inc.

Seattle, WA · US

RON R DUCK

Regulatory profile

164 submissions 160 cleared

98% clearance rate · Active in Cardiovascular

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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