Cleared Traditional

K983689 - BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES

K983689 is an FDA 510(k) clearance for BLUE SENSOR SUPATAB, manufactured by Medicotest A/S. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K983689 · Medicotest A/S · Cardiovascular device
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Jan 1999
Decision
87d
Days
Class 2
Risk

K983689 is an FDA 510(k) clearance for the BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Medicotest A/S (Washington, US). The FDA issued a Cleared decision on January 15, 1999 after a review of 87 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 Medicotest A/S devices

FDA 510(k) Submission Details - K983689

510(k) Number K983689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1998
Decision Date January 15, 1999
Days to Decision 87 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
38d faster than avg
Panel avg: 125d · This submission: 87d
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 156
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K983689.
CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002
K002230 · Cambridge Heart, Inc. · Aug 2000
ECG ELECTRODE (VARIOUS)
K991105 · Conmedcorp · Nov 1999
SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES
K982521 · Leonhard Lang Co. · Oct 1999
MEDI-TRACE 4103 NEONATAL ELECTRODE
K981964 · Graphic Controls Corp. · Nov 1998
ECG ELECTRODES APRON
K982470 · Tapuz Medical Technology , Ltd. · Oct 1998
3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360
K974445 · 3M Healthcare · Jul 1998