Cleared Traditional

K863159 - Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR

K863159 is the FDA 510(k) clearance for Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR by Quinton, Inc.. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K863159 · Quinton, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1986
Decision
49d
Days
Class 2
Risk

K863159 is an FDA 510(k) clearance for the Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on October 6, 1986 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 K863159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1986
Decision Date October 06, 1986
Days to Decision 49 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
76d faster than avg
Panel avg: 125d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 231
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K863159.
SPACELABS ARRHYTHMIA NET (TM) LEVEL 2
K864505 · Spacelabs, Inc. · Nov 1986
CASE 12
K862316 · Marquette Electronics, Inc. · Nov 1986
MODEL 6000 AMBULATORY ECG ANALYSIS SYSTEM
K863724 · Oxford Medilog, Inc. · Nov 1986
PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III
K860980 · Spacelabs, Inc. · May 1986
595 ARRHYTHMIA MONITORING SYSTEM
K852250 · Burdick Corp. · May 1986
SCM-400 HOLTER SYSTEM
K860950 · Fukuda Denshi USA, Inc. · May 1986