Cleared Traditional

K841401 - SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER

K841401 is the FDA 510(k) clearance for SAT-1 OXIMETER/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 286-day FDA review.

K841401 · American Edwards Laboratories · Cardiovascular device
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Jan 1985
Decision
286d
Days
Class 2
Risk

K841401 is an FDA 510(k) clearance for the SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by American Edwards Laboratories (Walker, US). The FDA issued a Cleared decision on January 14, 1985 after a review of 286 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

Submission Details

510(k) Number K841401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1984
Decision Date January 14, 1985
Days to Decision 286 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
161d slower than avg
Panel avg: 125d · This submission: 286d
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 K841401.
ELECATH CARDIAC OUTPUT COMPUTER
K844682 · Electro-Catheter Corp. · Mar 1985
COMPUTER
K844665 · Burdick Corp. · Feb 1985
RIGHT VENTRICULAR EJECTION FRACTION-
K842105 · 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
MODELS 78551A 78552A
K841256 · Hewlett-Packard Co. · Oct 1984