Home / 510(k) Clearances / K151650

510(k) K151650

SMARTez elastomeric infusion pump by Epic Medical Pte. , Ltd. — Product Code MEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2016
Date Received
June 18, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Pump, Infusion, Elastomeric
Device Class
Class II
Regulation Number
880.5725
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 MEB

  • K240624 — InfuLife (November 5, 2024)
  • K242152 — SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) (October 7, 2024)
  • K181360 — ON-Q* Pump with Bolus (March 22, 2019)
  • K131249 — ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES (February 3, 2014)
  • K131247 — MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM (August 14, 2013)
  • K090300 — MODIFICATION TO AUTOFUSER (April 30, 2009)
  • K081905 — ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP (July 15, 2008)
  • K071532 — ALPHA INFUSION PUMP, MODEL A200, A450 (February 19, 2008)
  • K072921 — DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM (November 26, 2007)
  • K072053 — SMARTBLOCK PAIN PUMP (November 6, 2007)