Cleared Traditional

QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH (K945626) - FDA 510(k) Clearance

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

K945626 · Quinton, Inc. · Cardiovascular device
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Jun 1995
Decision
224d
Days
Class 2
Risk

K945626 is an FDA 510(k) clearance for the QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Quinton, Inc. (Bothell, US). The FDA issued a Cleared decision on June 28, 1995 after a review of 224 days - an extended review 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: 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

Submission Details

510(k) Number K945626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1994
Decision Date June 28, 1995
Days to Decision 224 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 125d · This submission: 224d
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 K945626.
SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431)
K964784 · Quinton, Inc. · Aug 1997
HP CATHSTATION - MODEL M1264B
K961401 · Hewlett-Packard Co. · Oct 1996
HEWLETT-PACKARD MODEL M1264B CATHSTATION
K952173 · Hewlett-Packard Co. · Aug 1995
HP M1175A, M1176A, COMPONENT MONITORING SYSTEM
K941811 · Hewlett-Packard Co. · May 1994
MEDTRONIC MODEL 9455 TELETRACE III ECG MONIT SYST
K914974 · Medtronic Vascular · Dec 1991
Q4500 STREE TEST MONITOR
K910017 · Quinton, Inc. · Nov 1991