SMARTeZ Elastomeric Infusion Pump (RS series)— 510(k) K250234

Name: FDA 510(k) clearance K250234
Creator: U.S. Food and Drug Administration
Published: 2026-04-24

Substantially Equivalent

Epic Medical Pte. , Ltd.

FDA 510(k) clearance K250234 for SMARTeZ Elastomeric Infusion Pump (RS series), Substantially Equivalent on 2026-04-24. Applicant: Epic Medical Pte. , Ltd.. Device class: 2.

Clearance details

Applicant: Epic Medical Pte. , Ltd.
Product code: Code MEB
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2025-01-27
Decision date: 2026-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

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K131249 — ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES2014-02-03

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Adverse events under product code MEB

product code MEB

Death: 6
Injury: 160
Malfunction: 10,053
Other: 5
Total: 10,224

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.