Cleared Traditional

K914974 - MEDTRONIC MODEL 9455 TELETRACE III ECG ...

K914974 is the FDA 510(k) clearance for MEDTRONIC MODEL 9455 TELETRACE III ECG ... by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K914974 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
43d
Days
Class 2
Risk

K914974 is an FDA 510(k) clearance for the MEDTRONIC MODEL 9455 TELETRACE III ECG MONIT SYST. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on December 19, 1991 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 K914974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1991
Decision Date December 19, 1991
Days to Decision 43 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 125d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 250
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K914974.
TYPE 9050/NEO
K912183 · S & W Medico Teknik · Jun 1992
ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS
K920364 · Biosound, Inc. · Mar 1992
HL-300 RECEIVER MODULE
K915879 · Fukuda Denshi USA, Inc. · Jan 1992
Q4500 STREE TEST MONITOR
K910017 · Quinton, Inc. · Nov 1991
HORIZON 2000 ST ANALYSIS OPTION
K903524 · Mennen Medical, Inc. · Mar 1991
CARDIOFAX ECG-8830A
K904758 · Nihon Kohden America, Inc. · Dec 1990