Cleared Traditional

K842105 - RIGHT VENTRICULAR EJECTION FRACTION-

K842105 is an FDA 510(k) clearance for RIGHT VENTRICULAR EJECTION FRACTION-, manufactured by American Edwards Laboratories. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K842105 · American Edwards Laboratories · Cardiovascular device
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Jan 1985
Decision
235d
Days
Class 2
Risk

K842105 is an FDA 510(k) clearance for the RIGHT VENTRICULAR EJECTION FRACTION-. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by American Edwards Laboratories (Santa Ana, US). The FDA issued a Cleared decision on January 15, 1985 after a review of 235 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all American Edwards Laboratories devices

FDA 510(k) Submission Details - K842105

510(k) Number K842105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1984
Decision Date January 15, 1985
Days to Decision 235 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
110d slower than avg
Panel avg: 125d · This submission: 235d
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 107
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K842105.
ELECATH CARDIAC OUTPUT COMPUTER
K844682 · Electro-Catheter Corp. · Mar 1985
COMPUTER
K844665 · Burdick Corp. · Feb 1985
CARDIAC COMPUTER SP1445
K843555 · Gould, Inc. · Feb 1985
SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER
K841401 · American Edwards Laboratories · Jan 1985
RECOMED CARDIAC OUTPUT METER 236067-
K840439 · Litton Medical Electronics · Nov 1984
ELECATH VENTRICULAR PACING THERMAL DILUTION CATH
K844022 · Electro-Catheter Corp. · Nov 1984