SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)— 510(k) K242152

Name: FDA 510(k) clearance K242152
Creator: U.S. Food and Drug Administration
Published: 2024-10-07

Substantially Equivalent

Epic Medical Pte. , Ltd.

FDA 510(k) clearance K242152 for SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141), Substantially Equivalent on 2024-10-07. 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: 2024-07-23
Decision date: 2024-10-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Singapore, SG

Download summary PDF View 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, 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.