Cleared Traditional

K020382 - BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA

K020382 is an FDA 510(k) clearance for BLUE SENSOR, 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 143-day FDA review.

K020382 · Medicotest A/S · Cardiovascular device
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Jun 2002
Decision
143d
Days
Class 2
Risk

K020382 is an FDA 510(k) clearance for the BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA. 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 June 28, 2002 after a review of 143 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Medicotest A/S devices

FDA 510(k) Submission Details - K020382

510(k) Number K020382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2002
Decision Date June 28, 2002
Days to Decision 143 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 125d · This submission: 143d
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 157
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K020382.
SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL
K024247 · Leonhard Lang GmbH · Jan 2003
SKINTACT ECG ELECTRODE
K023503 · Leonhard Lang GmbH · Nov 2002
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
K020003 · Bio Protech, Inc. · Nov 2002
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