Cleared Traditional

K910871 - EDENTEC DIGITAL CHARTER MODEL 3710 (FDA 510(k) Clearance)

Class I Cardiovascular device.

K910871 · Edentec Corp. · Cardiovascular device
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Aug 1991
Decision
181d
Days
Class 1
Risk

K910871 is an FDA 510(k) clearance for the EDENTEC DIGITAL CHARTER MODEL 3710. 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 29, 1991 after a review of 181 days - an extended review cycle.

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

Submission Details

510(k) Number K910871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1991
Decision Date August 29, 1991
Days to Decision 181 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 125d · This submission: 181d
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.