# K252987: ADRx™ Admixture Device

- Pathway: 510(k) (Traditional)
- Applicant: Epic Medical Pte., Ltd.
- Decided: Jun 12, 2026 after 267 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K910793 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201415: Vial2Bag Advanced 20mm Admixture Device, West Pharmaceutical Services Az, Inc. (2020) Summary page 5.

## Indications for use
The ADRx™ Admixture Device is intended to connect an IV bag, a drug vial, and a standard external IV administration set. It facilitates the safe reconstitution of drug vials using diluents from the IV bag and enables the transfer of vial contents into the IV bag prior to patient administration.

Source page: https://510kreport.com/device/K252987
Methodology: https://510kreport.com/methodology