DeviceClearance

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.. Device class: 2.

Summary

Epic Medical's SMARTeZ Elastomeric Infusion Pump (RS series) is filed under product code MEB (Pump, Infusion, Elastomeric). The record doesn't describe the pump beyond its name and that code name.

Class II, 21 CFR 880.5725. General Hospital is both the classification panel and the review panel. It came in as a Traditional 510(k).

Epic Medical filed from Singapore. The record shows 452 calendar days from receipt to decision (January 27, 2025 to April 24, 2026).

Clearance details

Applicant
Epic Medical Pte. , Ltd.
Product code
Product code MEB
Device class
Class 2
Regulation
21 CFR 880.5725
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Singapore, SG
Download summary PDFView on FDA.gov ↗

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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, through . 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.