Cleared Traditional

K821802 - CENTURION ELECTRODE BELT

K821802 is an FDA 510(k) clearance for CENTURION ELECTRODE BELT, manufactured by Clinical Data, Inc.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K821802 · Clinical Data, Inc. · Cardiovascular device
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Jul 1982
Decision
45d
Days
Class 2
Risk

K821802 is an FDA 510(k) clearance for the CENTURION ELECTRODE BELT. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Clinical Data, Inc. (Walker, US). The FDA issued a Cleared decision on July 30, 1982 after a review of 45 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 Clinical Data, Inc. devices

FDA 510(k) Submission Details - K821802

510(k) Number K821802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1982
Decision Date July 30, 1982
Days to Decision 45 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 125d · This submission: 45d
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 152
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K821802.
QUIK-SILVER RESTING ECG ELECTRODE
K830655 · Quinton, Inc. · Jun 1983
MEDI-TRACE 5' OFFSET ELECTRODE
K822750 · Graphic Controls Corp. · Nov 1982
DISPOSABLE ELECTRODE #1900
K822798 · Andover Medical, Inc. · Oct 1982
LDS MONITORING ELECTRODE
K821846 · Life Design Systems, Inc. · Jul 1982
QUIK - PREP2 ELECTRODE
K821757 · Quinton, Inc. · Jul 1982
RED DOT MONITORING ELECTRODES #2260/65
K821438 · 3M Company · May 1982