510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831967Substantially Equivalent

Critikon Cardiac Output Computer

Critikon Company, LLC, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831967 is the FDA 510(k) clearance record for CRITIKON CARDIAC OUTPUT COMPUTER, a class II device, cleared for Critikon Company, LLC on under FDA product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function). FDA records list 51 510(k) clearances for Critikon Company, LLC, from to . As of , FDA records show no recalls naming K831967.

Clearance record

Decision date
Received
(130 days to decision)
Product code
DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Regulation
21 CFR 870.1435
Device class
Class II
Review panel
Cardiovascular
Applicant
Critikon Company, LLC 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code DXG

Trailing 12 months
1 clearance under product code DXG in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260