510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031741Substantially Equivalent

Medley Etco2 Module (Includes Accessories), Model 8300

CareFusion 303, Inc, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031741 is the FDA 510(k) clearance record for MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300, a class II device, cleared for Alaris Medical Systems, Inc. on under FDA product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). FDA records list 26 510(k) clearances for CareFusion 303, INC, from to . As of , FDA records show 2 recalls naming K031741.

Clearance record

Decision date
Received
(250 days to decision)
Product code
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Regulation
21 CFR 868.1400
Device class
Class II
Review panel
Anesthesiology
Applicant
Alaris Medical Systems, Inc. 10221 Wateridge Cir., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CCK

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