# K973654: Vial-Mate Reconstitution Device (2B8071)

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Oct 24, 1997 after 29 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910793 (1991). 1 ancestor in all.
7 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)
- K910793: Reconstitution Device, Baxter Healthcare Corp (1991) Summary page 1.

## Most influential descendants
- K142600: VIAL-MATE Adaptor (2014), 6 descendants of its own
- 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

## Recalls of this device
- Sep 25, 2013 · Class II · Z-0392-2014: Incomplete foil seal on one lot of sterile product.

## Indications for use
The proposed Vial-Mate Reconstitution Device has the same intended use as previously cleared devices of its type. The Vial-Mate Reconstitution Device is intended to provide the pharmacist or health practitioner a means of connecting a standard 20 mm single dose drug vial to an LV. 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/K973654
Methodology: https://510kreport.com/methodology