510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K012383Substantially Equivalent

Gemini Pc-1,Pc-2, Pc-2Tx,pc-4, Signature Edition Infusion Pump (Se), Medsystem III Infusion (Msiii), Medsystem Patient C

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

K012383 is the FDA 510(k) clearance record for GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C, a class II device, cleared for Alaris Medical Systems, Inc. on under FDA product code FRN (Pump, Infusion). FDA records list 26 510(k) clearances for CareFusion 303, INC, from to . As of , FDA records show 12 recalls naming K012383.

Clearance record

Decision date
Received
(67 days to decision)
Product code
FRN Pump, Infusion
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
Third party review
No

Clearances, product code FRN

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