Cleared Traditional

K910870 - EDENTEC MODEL 3711 DIGITAL RECORDER

K910870 is the FDA 510(k) clearance for EDENTEC MODEL 3711 DIGITAL RECORDER by Edentec Corp.. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K910870 · Edentec Corp. · Cardiovascular device
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Aug 1991
Decision
181d
Days
Class 2
Risk

K910870 is an FDA 510(k) clearance for the EDENTEC MODEL 3711 DIGITAL RECORDER. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special 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 870.2300 - 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 K910870 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. No clinical trials required.

Device Classification

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 82
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K910870.
HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING
K921194 · Hewlett-Packard Co. · Nov 1992
MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED
K910665 · Ge Medical Systems Information Technologies · Dec 1991
DATASCOPE PASSPORT MONITOR
K911598 · Datascope Corp. · Oct 1991
HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A
K911139 · Hewlett-Packard Co. · Jun 1991
WEP-8430A TELEMETRY CENTRAL STATION
K904696 · Nihon Kohden America, Inc. · Feb 1991
MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL
K901034 · Nihon Kohden America, Inc. · Apr 1990