Cleared Traditional

K802316 - PDS THERMAL DILUTION CARDIAC MODULE(OUT)

K802316 is the FDA 510(k) clearance for PDS THERMAL DILUTION CARDIAC MODULE(OUT) by General Electric Co.. It is a Class 2 Cardiovascular device (product code DXG) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K802316 · General Electric Co. · Cardiovascular device
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Nov 1980
Decision
64d
Days
Class 2
Risk

K802316 is an FDA 510(k) clearance for the PDS THERMAL DILUTION CARDIAC MODULE(OUT). Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by General Electric Co. (Mchenry, US). The FDA issued a Cleared decision on November 26, 1980 after a review of 64 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 General Electric Co. devices

Submission Details

510(k) Number K802316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1980
Decision Date November 26, 1980
Days to Decision 64 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
61d faster than avg
Panel avg: 125d · This submission: 64d
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 80
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