Cleared Traditional

CARDIAC CATHETERIZATION LAB MONITOR SYS (K770179) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K770179 · General Electric Co. · Cardiovascular device
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Apr 1977
Decision
68d
Days
Class 2
Risk

K770179 is an FDA 510(k) clearance for the CARDIAC CATHETERIZATION LAB MONITOR SYS. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by General Electric Co. (Walker, US). The FDA issued a Cleared decision on April 5, 1977 after a review of 68 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 K770179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1977
Decision Date April 05, 1977
Days to Decision 68 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
57d faster than avg
Panel avg: 125d · This submission: 68d
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 24
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K770179.
MODEL 78554A DATA MGMT. PLUG-IN MODULE
K822877 · Hewlett-Packard Co. · Oct 1982
PDS THERMAL DILUTION CARDIAC MODULE(OUT)
K802316 · General Electric Co. · Nov 1980
CARDIAC OUTPUT THERMODILUTION MODULE
K771991 · Abbott Laboratories · Nov 1977
TIME-SHARING MULTIPLEXER (MODEL 78308A)
K760774 · Hewlett-Packard Co. · Oct 1976