Cleared Traditional

K950488 - GRAPHIC CONTROLS BIOTAC ECO ELECTRODE

K950488 is the FDA 510(k) clearance for GRAPHIC CONTROLS BIOTAC ECO ELECTRODE by Graphic Controls Corp.. It is a Class 2 Cardiovascular device (product code DRX) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K950488 · Graphic Controls Corp. · Cardiovascular device
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Jul 1995
Decision
147d
Days
Class 2
Risk

K950488 is an FDA 510(k) clearance for the GRAPHIC CONTROLS BIOTAC ECO ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Graphic Controls Corp. (Buffalo, US). The FDA issued a Cleared decision on July 3, 1995 after a review of 147 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 Graphic Controls Corp. devices

Submission Details

510(k) Number K950488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1995
Decision Date July 03, 1995
Days to Decision 147 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
22d slower than avg
Panel avg: 125d · This submission: 147d
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 83
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K950488.
CONMED 2710 CLEARTRACE 2 LT MONITORING ECG ELECTRODE
K954388 · Conmedcorp · Feb 1996
MEDI-TRACE(R) 500 ECG ELECTRODE
K945479 · Graphic Controls Corp. · Jul 1995
GRAPHIC CONTROLS PROTRACE ECG ELECTRODE
K950485 · Graphic Controls Corp. · Jul 1995
GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE
K950489 · Graphic Controls Corp. · Jul 1995
GRAPHIC CONTROLS Q-TRACE ECG ELECTRODE
K950486 · Graphic Controls Corp. · May 1995
GRAPHIC CONTROLS Q-TRACE GOLD ECG ELECTRODE
K950487 · Graphic Controls Corp. · May 1995