Cleared Traditional

K840439 - RECOMED CARDIAC OUTPUT METER 236067-

K840439 is the FDA 510(k) clearance for RECOMED CARDIAC OUTPUT METER 236067- by Litton Medical Electronics. It is a Class 2 Cardiovascular device (product code DXG) cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K840439 · Litton Medical Electronics · Cardiovascular device
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Nov 1984
Decision
293d
Days
Class 2
Risk

K840439 is an FDA 510(k) clearance for the RECOMED CARDIAC OUTPUT METER 236067-. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Litton Medical Electronics (Elk Grove Village, US). The FDA issued a Cleared decision on November 20, 1984 after a review of 293 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 Litton Medical Electronics devices

Submission Details

510(k) Number K840439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1984
Decision Date November 20, 1984
Days to Decision 293 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 125d · This submission: 293d
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 54
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K840439.
MODEL 78231D CARDIAC OUTPUT MODULE
K850568 · Hewlett-Packard Co. · Apr 1985
RIGHT VENTRICULAR EJECTION FRACTION-
K842105 · American Edwards Laboratories · Jan 1985
SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER
K841401 · American Edwards Laboratories · Jan 1985
MODELS 78551A 78552A
K841256 · Hewlett-Packard Co. · Oct 1984
HEMODYNAMIC PLUG-IN MODULE 78551A
K833913 · Hewlett-Packard Co. · Mar 1984
CARDIAC OUTPUT SIGNAL ACQUISTION
K833914 · Hewlett-Packard Co. · Mar 1984