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510(k) K251139

KabiHelp® Uno; KabiHelp® Advance plus by Fresenius Kabi AG — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2026
Date Received
April 14, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, I.V.
Device Class
Class II
Regulation Number
880.5025
Review Panel
HO
Submission Type

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Other clearances for product code KPE

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  • K241442 — eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (June 21, 2024)
  • K223674 — eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) (September 1, 2023)
  • K222622 — Disposable Infusion Bag for Parenteral Nutrition (February 16, 2023)
  • K210749 — Empty EVA Bag (August 19, 2021)
  • K201936 — SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL (May 6, 2021)
  • K193528 — Empty EVA Bag (July 22, 2020)
  • K190328 — HCT Empty EVA Container Pack (August 15, 2019)
  • K190305 — Additive Cap (April 30, 2019)