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510(k) K241442

eZSURE™ Empty Fluid Container with ProSeal™ Injection Site by Epic Medical Pte. , Ltd. — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2024
Date Received
May 22, 2024
Clearance Type
Special
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

Other clearances by Epic Medical Pte. , Ltd.

  • K251722 — ProSeal™ Transfer Injector (421120, 421130, 421140) (December 5, 2025)
  • K251814 — EZ™ IV Administration Set (August 29, 2025)
  • K252094 — eZSURE™ Empty Fluid Container (August 1, 2025)
  • K251340 — ProSeal™ Bag Spike with Additive Port (423370ST, 423370) (May 29, 2025)
  • K243976 — ZeroClear™ Bag Access (423100) (January 22, 2025)
  • K240517 — ProSeal™ Vented Universal Vial Adaptor (December 26, 2024)
  • K241988 — ProSeal™ Closed System Bag Access (October 23, 2024)
  • K241735 — ProSeal™ In Line Pump Set (423850) (October 10, 2024)
  • K242152 — SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) (October 7, 2024)
  • K241823 — ToxiSeal™ Vial Adaptor (August 30, 2024)

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)
  • 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)