# K910793: Reconstitution Device

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Mar 21, 1991 after 24 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
No predicates in its family tree.
8 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K973654: Vial-Mate Reconstitution Device (2B8071) (1997), 7 descendants of its own
- 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

Source page: https://510kreport.com/device/K910793
Methodology: https://510kreport.com/methodology