# K900865: Add-a-Vial II Binary Connector

- Pathway: 510(k) (Traditional)
- Applicant: Kendall Mcgaw Laboratories, Inc.
- Decided: Jul 11, 1990 after 138 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K090905: Addease 20MM Binary Connector with 17 GA. Needle (2009), 3 descendants of its own
- K192154: Rio Vial-to-Bag Drug Reconstitution Device (2020), 1 descendant of its own
- K243985: Rio™ Drug Reconstitution Transfer Device (2025), 0 descendants of its own
- K133602: Add-Vantage Addaptor (2014), 0 descendants of its own
- K973593: Bridge Sentry Bedside Unit, Bridge Sentry Administration Set-Standard Configuration, Bridge Sentry Administration Set 5 (1998), 0 descendants of its own

## Recalls of this device
- Apr 4, 2013 · Class II · Z-0424-2014: Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Based on extensive root cause investigation, it has been determined
- Apr 4, 2013 · Class II · Z-0425-2014: Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Based on extensive root cause investigation, it has been determined

Source page: https://510kreport.com/device/K900865
Methodology: https://510kreport.com/methodology