510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043299Substantially Equivalent

Medley Pca Module, Model 8120

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

K043299 is the FDA 510(k) clearance record for MEDLEY PCA MODULE, MODEL 8120, a class II device, cleared for Alaris Medical Systems, Inc. on under FDA product code MEA (Pump, Infusion, Pca). FDA records list 26 510(k) clearances for CareFusion 303, INC, from to . As of , FDA records show 3 recalls naming K043299.

Clearance record

Decision date
Received
(10 days to decision)
Product code
MEA Pump, Infusion, Pca
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Alaris Medical Systems, Inc. 10221 Wateridge Cir., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MEA

Trailing 12 months

FDA records hold no clearances under product code MEA in the trailing twelve months.

FDA records show no clearances under product code MEA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MEA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260