ADRx™ Admixture Device
FDA 510(k) clearance K252987 · decided 2026-06-12
Clearance details
- K-number
- K252987
- Device name
- ADRx™ Admixture Device
- Applicant
- Epic Medical Pte. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-18
- Decision date
- 2026-06-12
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Singapore, SG
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.