510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844227Substantially Equivalent

Infusart

Sartorius, Inc., Gottingen, Germany, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844227 is the FDA 510(k) clearance record for INFUSART, a class II device, cleared for Sartorius, Inc. on under FDA product code FLN (Monitor, Electric For Gravity Flow Infusion Systems). FDA records list one 510(k) clearance for Sartorius, Inc. As of , FDA records show no recalls naming K844227.

Clearance record

Decision date
Received
(82 days to decision)
Product code
FLN Monitor, Electric For Gravity Flow Infusion Systems
Regulation
21 CFR 880.2420
Device class
Class II
Review panel
General Hospital
Applicant
Sartorius, Inc. Postfach 3243, Gottingen, Germany, DE
Third party review
No

Clearances, product code FLN

Trailing 12 months

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

FDA records show no clearances under product code FLN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FLN, 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