# K090905: Addease 20MM Binary Connector with 17 GA. Needle

- Pathway: 510(k) (Special)
- Applicant: B.Braun Medical, Inc.
- Decided: Apr 27, 2009 after 26 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K900865 (1990). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900865: Add-a-Vial II Binary Connector, Kendall Mcgaw Laboratories, Inc. (1990) Summary page 1.

## Most influential descendants
- 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

## 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
- Jun 24, 2010 · Not classified · Z-0305-2011: During this insertion, fragmentation of the PAB container stopper may occur resulting in a small amount of visible particulates in the solution.
- Jun 24, 2010 · Not classified · Z-0306-2011: During this insertion, fragmentation of the PAB container stopper may occur resulting in a small amount of visible particulates in the solution.

## Indications for use
The addEASE 20 mm Binary Connector with 17 Ga. Needle is a double ended transfer device intended for use in a pharmacy setting to connect a B. Braun 250mL Excel® IV solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.

Source page: https://510kreport.com/device/K090905
Methodology: https://510kreport.com/methodology