# K040634: Robertsite Vial Adapter, Model 245700021

- Pathway: 510(k) (Traditional)
- Applicant: Halkey-Roberts Corp.
- Decided: Mar 23, 2004 after 13 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
Longest line of descent: 2 generations back to K790472 (1979). 3 ancestors in all.
5 later devices descend from it; 3 cite it directly.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013087: Single Dose Dispensing Pin, Model 2201, Alaris Medical Systems, Inc. (2001) Summary page 2.

## Most influential descendants
- K072759: VIAL2BAG (2007), 2 descendants of its own
- K140730: VIAL2BAG Direct Connect (2014), 1 descendant of its own
- K170095: Vial2Bag Direct Connect (2017), 0 descendants of its own
- K072511: Swabable Vial Adapter 13MM, Swabable Vial Adapter 20MM (2007), 0 descendants of its own
- K061143: Robertsite Stopcock (2006), 0 descendants of its own

## Indications for use
Robertsite* Vial Adapter is indicated to allow multiple needleless access to an injection medication vial for the purpose of facilitating the withdrawal or addition of drugs/solutions from or to the vial.

Source page: https://510kreport.com/device/K040634
Methodology: https://510kreport.com/methodology