Cleared Traditional

K830892 - THERMODILUTION CARDIAC OUTPUT COMPUTER-

K830892 is the FDA 510(k) clearance for THERMODILUTION CARDIAC OUTPUT COMPUTER- by American Edwards Laboratories. It is a Class 2 Cardiovascular device (product code DXG) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K830892 · American Edwards Laboratories · Cardiovascular device
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Jun 1983
Decision
86d
Days
Class 2
Risk

K830892 is an FDA 510(k) clearance for the THERMODILUTION CARDIAC OUTPUT COMPUTER-. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by American Edwards Laboratories (Mchenry, US). The FDA issued a Cleared decision on June 15, 1983 after a review of 86 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 American Edwards Laboratories devices

Submission Details

510(k) Number K830892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1983
Decision Date June 15, 1983
Days to Decision 86 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
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 78
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K830892.
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K822877 · Hewlett-Packard Co. · Oct 1982