Cleared Traditional

K893561 - EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. (FDA 510(k) Clearance)

Class I Cardiovascular device.

K893561 · Edentec Corp. · Cardiovascular device
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Aug 1989
Decision
108d
Days
Class 1
Risk

K893561 is an FDA 510(k) clearance for the EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Edentec Corp. (Eden Prairie, US). The FDA issued a Cleared decision on August 25, 1989 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2810 - 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.

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Submission Details

510(k) Number K893561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1989
Decision Date August 25, 1989
Days to Decision 108 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 125d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DSF Recorder, Paper Chart
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.2810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.