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

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..

Clearance details

Applicant: Epic Medical Pte. , Ltd.
Product code: Code MEB
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 ↗

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.