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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2026-04-24 under 510(k) 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. The listed applicant is Epic Medical Pte. , Ltd.. The 510(k) number is K250234.

When did SMARTeZ™ Elastomeric Infusion Pump (RS series) receive FDA 510(k) clearance?

SMARTeZ™ Elastomeric Infusion Pump (RS series) received FDA 510(k) clearance on 2026-04-24, under 510(k) number K250234.

Who is the listed applicant for SMARTeZ™ Elastomeric Infusion Pump (RS series)?

The FDA 510(k) record lists Epic Medical Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Epic Medical Pte. , Ltd. as applicant

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Related Devices (Code: MEB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240624InfuLifeFirst Medical Source, LLCK242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte. , Ltd.K181360ON-Q* Pump with BolusHalyard HealthK151650SMARTez elastomeric infusion pumpEpic Medical Pte. , Ltd.

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.

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