Cleared Traditional

K871668 - BIODAN TYPE COMET ELECTRODE

K871668 is an FDA 510(k) clearance for BIODAN TYPE COMET ELECTRODE, manufactured by National Medical Technology. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K871668 · National Medical Technology · Cardiovascular device
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Jun 1987
Decision
43d
Days
Class 2
Risk

K871668 is an FDA 510(k) clearance for the BIODAN TYPE COMET ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by National Medical Technology (Quebec, Canada, CA). The FDA issued a Cleared decision on June 10, 1987 after a review of 43 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 National Medical Technology devices

FDA 510(k) Submission Details - K871668

510(k) Number K871668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1987
Decision Date June 10, 1987
Days to Decision 43 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 125d · This submission: 43d
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 97
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K871668.
PRE-GELLED DISPOSABLE ECG TAPE ELECTRODE HP40489E
K874424 · Hewlett-Packard Co. · Jan 1988
TRACETS 3000
K875015 · Lectec Corp. · Jan 1988
MACTRODE-II
K872784 · Marquette Electronics, Inc. · Oct 1987
MD MONITORING/DIAGNOSTIC ELECTRODE
K870873 · Lectec Corp. · Apr 1987
S&W ELECTRODE TYPES 888, 844, 988 AND 944
K864586 · S & W Medico Teknik · Mar 1987
TRACETS 2000/ELECTRODES
K863674 · Lectec Corp. · Mar 1987