510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K041550Substantially Equivalent

Hospira Phoenix Infusion System with Hospira Mednet Software

Abbott Medical, Abbott Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041550 is the FDA 510(k) clearance record for HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE, a class II device, cleared for Abbott Laboratories on under FDA product code FRN (Pump, Infusion). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show 36 recalls naming K041550.

Clearance record

Decision date
Received
(21 days to decision)
Product code
FRN Pump, Infusion
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Abbott Laboratories D-389, Bldg. J45-2, Abbott Park IL
510(k) summary
Summary PDF
Third party review
Yes

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