Cleared Traditional

K915769 - MODIFIED MEMORYTRACE ER MODEL 4221 ECG ...

K915769 is the FDA 510(k) clearance for MODIFIED MEMORYTRACE ER MODEL 4221 ECG ... by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DXH) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K915769 · Medtronic Vascular · Cardiovascular device
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Jan 1992
Decision
37d
Days
Class 2
Risk

K915769 is an FDA 510(k) clearance for the MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR. 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 January 30, 1992 after a review of 37 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 K915769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1991
Decision Date January 30, 1992
Days to Decision 37 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
88d faster than avg
Panel avg: 125d · This submission: 37d
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
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K912379 · Cardiac Pacemakers, Inc. · Jun 1991