Cleared Traditional

K893561 - EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.

K893561 is an FDA 510(k) clearance for EDENTRACE 670 SYSTEM MULTICHANNEL RECOR..., manufactured by Edentec Corp.. The device is a Class 1 Cardiovascular device with product code DSF cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K893561 · Edentec Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Edentec Corp. devices

FDA 510(k) Submission Details - K893561

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 125d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

DSF Device Classification - Class 1, General Controls

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.

Regulatory Peers - DSF Recorder, Paper Chart

All 56
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K893561.
MODEL 556 MONITOR
K905856 · Ge Medical Systems Information Technologies · Jan 1991
COLORADO COLOR IMAGING RECORDER
K902230 · Honeywell, Inc. · Jun 1990
TYPE 9541 RECORDER, PAPER CHART
K895111 · S & W Medico Teknik · Jan 1990
CARDIOCAP(TM) DR-104 REPORTER
K885058 · Datex Division Instrumentarium Corp. · Jul 1989
FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER
K884897 · Mennen Medical, Inc. · Mar 1989
EDENTEC MODEL 4700 SCANNER
K884388 · Edentec Corp. · Jan 1989