# K963012: Bioject Needle-Free Vial Adapter (13MM)

- Pathway: 510(k) (Traditional)
- Applicant: Bioject, Inc.
- Decided: Oct 15, 1996 after 74 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: 1 generation back to K894177 (1989). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894177: Needle*Less Drug Vial Adapter, Baxter Healthcare Corp (1989) Summary page 1.
- K920737: Lifeshield Vial Adapter, Abbott Laboratories (1992) Summary page 1.

## Most influential descendants
- K041691: Clip 'N'ject Reconstitution System (Clip 'N'ject (2004), 3 descendants of its own
- K070584: Smart-Rod (2008), 2 descendants of its own
- K133097: E-Z Link (2014), 1 descendant of its own
- K161800: OnSite-IV (2016), 0 descendants of its own
- K041564: Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01 (2004), 0 descendants of its own

## Indications for use
The intended use of the Bioject Needle-Free Vial Adapter is to allow single access to 13 mm drug vials for withdrawal of medications, withdrawal and transfer of diluents, and reconstitution and withdrawal of medications, without the use of needles. The Bioject Needle-Free Vial Adapter may be used by physicians, nurses, and other practitioners who routinely administer injections, or by patients and other individuals authorized by their physicians to administer injections of prescribed medication.

Source page: https://510kreport.com/device/K963012
Methodology: https://510kreport.com/methodology