510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K251139Substantially Equivalent

KabiHelp® Uno; KabiHelp® Advance plus

Fresenius Kabi AB, Bad Homburg, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251139 is the FDA 510(k) clearance record for KabiHelp® Uno; KabiHelp® Advance plus, a class II device, cleared for Fresenius Kabi AG on under FDA product code KPE (Container, I.V.). FDA records list 14 510(k) clearances for Fresenius Kabi AG, from to . As of , FDA records show no recalls naming K251139.

Clearance record

Decision date
Received
(270 days to decision)
Product code
KPE Container, I.V.
Regulation
21 CFR 880.5025
Device class
Class II
Review panel
General Hospital
Applicant
Fresenius Kabi AG Else-Kroner-Str.1, Bad Homburg, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KPE

Trailing 12 months
3 clearances under product code KPE 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 KPE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260