DeviceClearance

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.. Device class: 2.

Summary

Epic Medical's ADRx Admixture Device is filed under LHI, I.V. fluid transfer sets. The record doesn't expand "ADRx" or describe the device further.

Class II, 21 CFR 880.5440. 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 decision came 267 calendar days after receipt (September 18, 2025 to June 12, 2026).

Clearance details

Applicant
Epic Medical Pte. , Ltd.
Product code
Product code LHI
Device class
Class 2
Regulation
21 CFR 880.5440
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 LHI

product code LHI
Injury
207
Malfunction
7,820
Other
3
Total
8,030

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.