Cleared Traditional

K852971 - #9431 TELETRACE, TELEPHONE, EKG TRANSMITTER

K852971 is an FDA 510(k) clearance for #9431 TELETRACE, 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 99-day FDA review.

K852971 · Medtronic Vascular · Cardiovascular device
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Oct 1985
Decision
99d
Days
Class 2
Risk

K852971 is an FDA 510(k) clearance for the #9431 TELETRACE, TELEPHONE, EKG TRANSMITTER. 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 October 22, 1985 after a review of 99 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 - K852971

510(k) Number K852971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1985
Decision Date October 22, 1985
Days to Decision 99 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
26d faster than avg
Panel avg: 125d · This submission: 99d
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 K852971.
MEDTRONIC MODEL 4220 AMBULATORY ECG MONITOR
K870652 · Medtronic Vascular · May 1987
WEP 7604 TELEMETRY MONITOR
K854369 · Nihon Kohden America, Inc. · Feb 1986
CMS 8000
K853096 · Physio-Control Corp. · Jan 1986
R-1000 ECG RECEIVER
K851123 · Brentwood Instruments, Inc. · May 1985
T-1000 ECG TRANSMITTER
K851124 · Brentwood Instruments, Inc. · May 1985
MDE ESCORT 1000 & MDE ESCOR 2000
K842716 · Medical Data Electronics · Feb 1985