ADRx Admixture Device— 510(k) K252987

Substantially Equivalent

Epic Medical Pte. , Ltd.

FDA 510(k) clearance K252987 for ADRx Admixture Device, Substantially Equivalent on 2026-06-12. Applicant: Epic Medical Pte. , Ltd..

Clearance details

Applicant: Epic Medical Pte. , Ltd.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2025-09-18
Decision date: 2026-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.