Cleared Traditional

K780158 - TELETRACE TELEPHONE EKG TRANSMITTER

K780158 is the FDA 510(k) clearance for TELETRACE TELEPHONE EKG TRANSMITTER by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DXH) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K780158 · Medtronic Vascular · Cardiovascular device
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Mar 1978
Decision
50d
Days
Class 2
Risk

K780158 is an FDA 510(k) clearance for the TELETRACE TELEPHONE EKG TRANSMITTER. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on March 21, 1978 after a review of 50 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Vascular devices

Submission Details

510(k) Number K780158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1978
Decision Date March 21, 1978
Days to Decision 50 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
75d faster than avg
Panel avg: 125d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 92
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K780158.
MEDTRONIC MODEL 9410 TELETRACE RECEIVER
K791778 · Medtronic Vascular · Oct 1979
TRANSMITTER, TR-1 ECG
K782059 · Burdick Corp. · Dec 1978
TRANSMITTER, MODEL 9406 AND 9401
K781986 · Medtronic Vascular · Dec 1978
PATIENT ALERT MODEL 555
K772350 · Intermedics, Inc. · Mar 1978
ELECTROCARDIOGRAPH TRANSMITTER, 536
K772186 · Intermedics, Inc. · Feb 1978
TR-3 TRANSMITTER
K760857 · Burdick Corp. · Jan 1977