Cleared Traditional

K921164 - MODEL 1300 SOFTRACE II ELECTRODE

K921164 is the FDA 510(k) clearance for MODEL 1300 SOFTRACE II ELECTRODE by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 372-day FDA review.

K921164 · Medtronic Vascular · Cardiovascular device
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Mar 1993
Decision
372d
Days
Class 2
Risk

K921164 is an FDA 510(k) clearance for the MODEL 1300 SOFTRACE II ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Medtronic Vascular (Haverhill, US). The FDA issued a Cleared decision on March 18, 1993 after a review of 372 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - 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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K921164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1992
Decision Date March 18, 1993
Days to Decision 372 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
247d slower than avg
Panel avg: 125d · This submission: 372d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 - DRX Electrode, Electrocardiograph

All 80
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K921164.
MEDI-TRACE NEONATAL ECG ELECTRODE WITH PREATTACHED LEADWIRE
K945214 · Graphic Controls Corp. · Nov 1994
3M RED DOT 2234 RADIOLUCENT MONITORING ELECTRODE
K930312 · 3M Health Care, Ltd. · Sep 1993
3M RED DOT 2330 RESTING EKG ELECTRODE
K932454 · 3M Health Care, Ltd. · Aug 1993
MODEL 1850 ELECTRODE
K903918 · Medtronic Vascular · Oct 1990
SILVER MACTRODE
K902176 · Marquette Electronics, Inc. · Sep 1990
MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE
K901555 · Medtronic Vascular · Jul 1990