# K010623: Reconstitution Kit & Vial Connector

- Pathway: 510(k) (Traditional)
- Applicant: Bioject, Inc.
- Decided: Apr 5, 2001 after 34 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K060819: Cool.Click 2 (2006), 0 descendants of its own
- K041564: Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01 (2004), 0 descendants of its own

Source page: https://510kreport.com/device/K010623
Methodology: https://510kreport.com/methodology