Cleared Traditional

K893836 - EPLAB (ELECTROCARDIOGRAPHIC MONITOR)

K893836 is an FDA 510(k) clearance for EPLAB (ELECTROCARDIOGRAPHIC MONITOR), manufactured by Quinton Electrophysiology Corp.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K893836 · Quinton Electrophysiology Corp. · Cardiovascular device
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Sep 1989
Decision
107d
Days
Class 2
Risk

K893836 is an FDA 510(k) clearance for the EPLAB (ELECTROCARDIOGRAPHIC MONITOR). Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Quinton Electrophysiology Corp. (Markham, Ontario, CA). The FDA issued a Cleared decision on September 8, 1989 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 - K893836

510(k) Number K893836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1989
Decision Date September 08, 1989
Days to Decision 107 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 125d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSH Device Classification - Class 2, Special Controls

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - DSH Recorder, Magnetic Tape, Medical

All 95
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K893836.
PR4
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