Cleared Traditional

K832828 - CENTURION CARDIAC DETECTOR

K832828 is an FDA 510(k) clearance for CENTURION CARDIAC DETECTOR, manufactured by Clinical Data Instruments, Inc.. The device is a Class 1 Cardiovascular device with product code DRJ cleared through the Traditional 510(k) pathway after a 264-day FDA review.

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

FDA 510(k) Submission Details - K832828

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.

DRJ Device Classification - Class 1, General Controls

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.