SMARTez elastomeric infusion pump

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K151650 ↗

FDA Product Code

MEB

FDA applicant

Epic Medical Pte. , Ltd.

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• ADRx™ Admixture Device

  Class II

  FDA 510(k) K252987 Active Cleared 12 Jun 2026

• eZSURE™ Empty Fluid Container

  Class II

  FDA 510(k) K252094 Active Cleared 1 Aug 2025

• ProSeal™ Transfer Injector (421120, 421130, 421140)

  Class II

  FDA 510(k) K251722 Active Cleared 5 Dec 2025

• SMARTeZ™ Elastomeric Infusion Pump (RS series)

  Class II

  FDA 510(k) K250234 Active Cleared 24 Apr 2026

• SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)

  Class II

  FDA 510(k) K242152 Active Cleared 7 Oct 2024

• eZSURE Empty Fluid Container (models 426030, 426040, 426110)

  Class II

  FDA 510(k) K223674 Active Cleared 1 Sep 2023

See all devices from Epic Medical Pte., Ltd. →