Cleared Traditional

K890201 - RADIOLUCENT ECG ELECTRODE MODEL NO: 1680

K890201 is an FDA 510(k) clearance for RADIOLUCENT ECG ELECTRODE MODEL NO: 1680, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K890201 · Medtronic Vascular · Cardiovascular device
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Mar 1989
Decision
57d
Days
Class 2
Risk

K890201 is an FDA 510(k) clearance for the RADIOLUCENT ECG ELECTRODE MODEL NO: 1680. 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 15, 1989 after a review of 57 days - a notably fast clearance cycle.

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: 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

FDA 510(k) Submission Details - K890201

510(k) Number K890201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1989
Decision Date March 15, 1989
Days to Decision 57 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
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

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 179
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K890201.
VITATRACE
K893425 · Lectec Corp. · Jul 1989
F56 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 56MM
K884980 · S & W Medico Teknik · May 1989
BARD NEONATAL ECG MONITORING ELECTRODE
K891075 · C.R. Bard, Inc. · Mar 1989
F40 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 40MM
K884981 · S & W Medico Teknik · Mar 1989
M68 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE,68
K884982 · S & W Medico Teknik · Mar 1989
M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55
K884983 · S & W Medico Teknik · Mar 1989