Cleared Traditional

K844116 - CRITIKON CARDIAC OUTPUT COMPUTER W/HEMO...

K844116 is an FDA 510(k) clearance for CRITIKON CARDIAC OUTPUT COMPUTER W/HEMO..., manufactured by Critikon Company, LLC. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K844116 · Critikon Company, LLC · Cardiovascular device
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May 1985
Decision
217d
Days
Class 2
Risk

K844116 is an FDA 510(k) clearance for the CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Critikon Company, LLC (Tampa, US). The FDA issued a Cleared decision on May 28, 1985 after a review of 217 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 Critikon Company, LLC devices

FDA 510(k) Submission Details - K844116

510(k) Number K844116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1984
Decision Date May 28, 1985
Days to Decision 217 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
92d slower than avg
Panel avg: 125d · This submission: 217d
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 87
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K844116.
ARRHYTHMIA REVIEW STATION
K854136 · Marquette Electronics, Inc. · Dec 1985
DESERET THERMODILUTION CARDIAC OUTPUT
K841967 · Parke-Davis Co. · Aug 1985
FUKUDA DENSHI EH-11
K834059 · Fukuda Denshi USA, Inc. · Jun 1985
MODEL 78231D CARDIAC OUTPUT MODULE
K850568 · Hewlett-Packard Co. · Apr 1985
ELECATH CARDIAC OUTPUT COMPUTER
K844682 · Electro-Catheter Corp. · Mar 1985
COMPUTER
K844665 · Burdick Corp. · Feb 1985