Cleared Traditional

K820820 - CARDIO REVUE CENTER

K820820 is an FDA 510(k) clearance for CARDIO REVUE CENTER, manufactured by Diasonics, Inc.. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K820820 · Diasonics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1982
Decision
36d
Days
Class 2
Risk

K820820 is an FDA 510(k) clearance for the CARDIO REVUE CENTER. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Diasonics, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 29, 1982 after a review of 36 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 Diasonics, Inc. devices

FDA 510(k) Submission Details - K820820

510(k) Number K820820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1982
Decision Date April 29, 1982
Days to Decision 36 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
89d faster than avg
Panel avg: 125d · This submission: 36d
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 85
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K820820.
AUTOECHO
K822903 · Oxford Medilog, Inc. · Nov 1982
IL 801 THERMALDILUTION CARDIAC OUTPUT
K822972 · Instrumentation Laboratory CO · Nov 1982
MODEL 78554A DATA MGMT. PLUG-IN MODULE
K822877 · Hewlett-Packard Co. · Oct 1982
MODEL 4200 ELLESTAD STRESS TEST ANALYZER
K813222 · Del Mar Avionics · Dec 1981
ANERIOD GAUZE
K812932 · Abco Dealers, Inc. · Dec 1981
SORENSON THERMODILUTION CARDIAC COMPUT
K812757 · Sorensen Research · Nov 1981