SMARTeZ Elastomeric Infusion Pump (RS series)
K-Number: K250234 · 2026-04-24
ApplicantEpic Medical Pte. , Ltd.
Decision Date2026-04-24
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
SMARTeZ Elastomeric Infusion Pump (RS series) is a medical device manufactured by Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2026-04-24 under approval number K250234. The device is classified under product code MEB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SMARTeZ Elastomeric Infusion Pump (RS series)?
SMARTeZ Elastomeric Infusion Pump (RS series) is a medical device that received FDA 510(k) clearance on 2026-04-24. It is manufactured by Epic Medical Pte. , Ltd.. The 510(k) number is K250234.
When was SMARTeZ Elastomeric Infusion Pump (RS series) approved by the FDA?
SMARTeZ Elastomeric Infusion Pump (RS series) received FDA 510(k) clearance on 2026-04-24, under approval number K250234.
What company makes SMARTeZ Elastomeric Infusion Pump (RS series)?
SMARTeZ Elastomeric Infusion Pump (RS series) is manufactured by Epic Medical Pte. , Ltd..
What is the FDA product code for SMARTeZ Elastomeric Infusion Pump (RS series)?
The FDA product code for SMARTeZ Elastomeric Infusion Pump (RS series) is MEB.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.