Cleared Traditional

EP AMP, MODEL #901 (K925346) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 7
Devices cleared under the same product code (DRR) and FDA review panel - the closest regulatory comparables to K925346.
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
MODEL 15055A MAINFRAME
K791964 · Hewlett-Packard Co. · Oct 1979
AMPLIFIER MODULE, 78211A ECG
K772132 · Hewlett-Packard Co. · Nov 1977
PATIENT MONITORS MODELS 78701A/78702A
K771572 · Hewlett-Packard Co. · Aug 1977