Cleared Traditional

K925346 - EP AMP, MODEL #901

K925346 is an FDA 510(k) clearance for EP AMP, manufactured by Quinton Electrophysiology Corp.. The device is a Class 2 Cardiovascular device with product code DRR cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K925346 · Quinton Electrophysiology Corp. · Cardiovascular device
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Apr 1993
Decision
190d
Days
Class 2
Risk

K925346 is an FDA 510(k) clearance for the EP AMP, MODEL #901. Classified as Amplifier And Signal Conditioner, Biopotential (product code DRR), Class II - Special Controls.

Submitted by Quinton Electrophysiology Corp. (Markham, Ontario, CA). The FDA issued a Cleared decision on April 30, 1993 after a review of 190 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2050 - 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 Electrophysiology Corp. devices

FDA 510(k) Submission Details - K925346

510(k) Number K925346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1992
Decision Date April 30, 1993
Days to Decision 190 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 125d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRR Device Classification - Class 2, Special Controls

Product Code DRR Amplifier And Signal Conditioner, Biopotential
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2050
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 - DRR Amplifier And Signal Conditioner, Biopotential

All 13
Devices cleared under the same product code (DRR) and FDA review panel - the closest regulatory comparables to K925346.
EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391
K971570 · Quinton Electrophysiology Corp. · Dec 1997
HORIZON 9000/HIS OPTION AMPLIFIER
K914381 · Mennen Medical, Inc. · Jan 1992
CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED
K911935 · Gould, Inc. · Jul 1991
BARD BIOPOTENTIAL AMPLIFIER
K874441 · C.R. Bard, Inc. · Jan 1988
EPC FILTER
K813123 · Codman & Shurtleff, Inc. · Nov 1981
HP MODEL 8880A FILTER
K802686 · Hewlett-Packard Co. · Nov 1980