# K142600: VIAL-MATE Adaptor

- Pathway: 510(k) (Special)
- Applicant: Baxter Healthcare Corporation
- Decided: Nov 19, 2014 after 65 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: 2 generations back to K910793 (1991). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973654: Vial-Mate Reconstitution Device (2B8071), Baxter Healthcare Corp (1997) Summary page 6.

## Most influential descendants
- K201415: Vial2Bag Advanced 20mm Admixture Device (2020), 5 descendants of its own
- K230988: Vial2Bag Advanced® 13mm Admixture Device (2023), 1 descendant of its own
- K252987: ADRx™ Admixture Device (2026), 0 descendants of its own
- K240940: Vial2Bag Advanced® 20mm Admixture Device (2024), 0 descendants of its own
- K212525: Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices (2022), 0 descendants of its own

## Indications for use
To provide the pharmacist or health practitioner a means of connecting a standard 20 mm single dose drug vial to an I.V. solution container without mixing the vial contents with the diluent until immediately before administration of the reconstituted drug to the patient.

Source page: https://510kreport.com/device/K142600
Methodology: https://510kreport.com/methodology