Cleared Traditional

K910017 - Q4500 STREE TEST MONITOR

K910017 is an FDA 510(k) clearance for Q4500 STREE 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 306-day FDA review.

K910017 · Quinton, Inc. · Cardiovascular device
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Nov 1991
Decision
306d
Days
Class 2
Risk

K910017 is an FDA 510(k) clearance for the Q4500 STREE 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 November 5, 1991 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K910017

510(k) Number K910017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1991
Decision Date November 05, 1991
Days to Decision 306 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
181d slower than avg
Panel avg: 125d · This submission: 306d
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 K910017.
ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS
K920364 · Biosound, Inc. · Mar 1992
HL-300 RECEIVER MODULE
K915879 · Fukuda Denshi USA, Inc. · Jan 1992
MEDTRONIC MODEL 9455 TELETRACE III ECG MONIT SYST
K914974 · Medtronic Vascular · Dec 1991
COORDINATOR, CABLE INPUT
K914725 · Cardiotronics, Inc. · Nov 1991
CARDIOCAP II TM CH-RESP MONITORS
K904355 · Instrumentarium Corp. · May 1991
HORIZON 2000 ST ANALYSIS OPTION
K903524 · Mennen Medical, Inc. · Mar 1991