Cleared Traditional

K883855 - PREDICTOR II SIGNAL AVERAGING ECG

K883855 is an FDA 510(k) clearance for PREDICTOR II SIGNAL AVERAGING ECG, manufactured by Corazonix Corp.. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K883855 · Corazonix Corp. · Cardiovascular device
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Nov 1988
Decision
51d
Days
Class 2
Risk

K883855 is an FDA 510(k) clearance for the PREDICTOR II SIGNAL AVERAGING ECG. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Corazonix Corp. (Oklahoma City, US). The FDA issued a Cleared decision on November 3, 1988 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - 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 Corazonix Corp. devices

FDA 510(k) Submission Details - K883855

510(k) Number K883855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1988
Decision Date November 03, 1988
Days to Decision 51 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 125d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXG Device Classification - Class 2, Special Controls

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 116
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K883855.
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