Cleared Traditional

K893471 - MEDTRONIC MODEL 9444 TELETRACE II ECG MONITORING

K893471 is an FDA 510(k) clearance for MEDTRONIC MODEL 9444 TELETRACE II ECG M..., manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K893471 · Medtronic Vascular · Cardiovascular device
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Sep 1989
Decision
145d
Days
Class 2
Risk

K893471 is an FDA 510(k) clearance for the MEDTRONIC MODEL 9444 TELETRACE II ECG MONITORING. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on September 26, 1989 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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 Medtronic Vascular devices

FDA 510(k) Submission Details - K893471

510(k) Number K893471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1989
Decision Date September 26, 1989
Days to Decision 145 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
20d slower than avg
Panel avg: 125d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXH Device Classification - Class 2, Special Controls

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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 - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 175
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K893471.
KING OF HEARTS 1200 MONITOR
K896039 · Instromedix, Inc. · Feb 1990
CARRY-ALL EKG TRANSTELEPHONIC TRANSMITTER
K896002 · Instromedix, Inc. · Jan 1990
TELEMETRY RECEIVER ACCESSORY FOR THE CMS 8000
K894540 · Physio-Control Corp. · Oct 1989
M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME
K894277 · Hewlett-Packard Co. · Sep 1989
MEDTRONIC MODEL 9443 IN-OFFICE TRANSMITTER
K894140 · Medtronic Vascular · Jul 1989
OXINET N-7500 PULSE OXIMETRY NETWORK
K884142 · Nellcor, Inc. · Dec 1988