Cleared Traditional

CENTURION CARDIAC DETECTOR (K832828) - FDA 510(k) Clearance

Class I Cardiovascular device.

K832828 · Clinical Data Instruments, Inc. · Cardiovascular device
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May 1984
Decision
264d
Days
Class 1
Risk

K832828 is an FDA 510(k) clearance for the CENTURION CARDIAC DETECTOR. Classified as System, Signal Isolation (product code DRJ), Class I - General Controls.

Submitted by Clinical Data Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on May 9, 1984 after a review of 264 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2600 - 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 Clinical Data Instruments, Inc. devices

Submission Details

510(k) Number K832828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1983
Decision Date May 09, 1984
Days to Decision 264 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 125d · This submission: 264d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DRJ System, Signal Isolation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.2600
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.