Home / 510(k) Clearances / K090096

510(k) K090096

ALL-IN-ONE CONTAINER by Baxter Healthcare Corporation — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2009
Date Received
January 15, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Baxter Healthcare Corporation

  • K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) (December 16, 2025)
  • K251640 — SIGMA Spectrum Infusion Pump with Master Drug Library (July 28, 2025)
  • K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) (July 28, 2025)
  • K243529 — Solution Administration Sets (March 14, 2025)
  • K242339 — Intravascular Extension Sets and Accessories (February 28, 2025)
  • K242390 — Novum IQ Syringe Pump (40800BAXUS) (September 5, 2024)
  • K241564 — Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE M (August 2, 2024)
  • K230665 — Dose IQ Safety Software (March 29, 2024)
  • K211122 — Novum IQ Large Volume Pump (March 29, 2024)
  • K232467 — CleanCart A, CleanCart C, AK 98 Hemodialysis Machine (September 14, 2023)

Other clearances for product code KPE

  • K251139 — KabiHelp® Uno; KabiHelp® Advance plus (January 9, 2026)
  • K252094 — eZSURE™ Empty Fluid Container (August 1, 2025)
  • K250459 — DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 5 (April 18, 2025)
  • 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)