Cleared Traditional

MEDITRACE PELLET ELECTRODE (K821137) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K821137 · Graphic Controls Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1982
Decision
28d
Days
Class 2
Risk

K821137 is an FDA 510(k) clearance for the MEDITRACE PELLET ELECTRODE. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Graphic Controls Corp. (Mchenry, US). The FDA issued a Cleared decision on May 18, 1982 after a review of 28 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 Graphic Controls Corp. devices

Submission Details

510(k) Number K821137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1982
Decision Date May 18, 1982
Days to Decision 28 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
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 23
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K821137.
QUIK-SILVER RESTING ECG ELECTRODE
K830655 · Quinton, Inc. · Jun 1983
QUIK - PREP2 ELECTRODE
K821757 · Quinton, Inc. · Jul 1982
RED DOT MONITORING ELECTRODES #2260/65
K821438 · 3M Company · May 1982
QUINTON LTE ELECTRODE
K810563 · Quinton, Inc. · Mar 1981
BARD BIOMEDICAL PRINTED SILVER ELECTRODE
K792040 · C.R. Bard, Inc. · Nov 1979
ELECTRODE SYSTEM, QUIK-PREP
K782079 · Quinton, Inc. · Feb 1979