# K894177: Needle*Less Drug Vial Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Sep 12, 1989 after 89 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K963012: Bioject Needle-Free Vial Adapter (13MM) (1996), 5 descendants of its own
- 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

Source page: https://510kreport.com/device/K894177
Methodology: https://510kreport.com/methodology