# K962893: Interlink Adapter for Conventional Y-Site

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Oct 18, 1996 after 85 days
- Product code: FPA (Set, Administration, Intravascular)
- 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 K914048 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914048: Needle*Lock (TM) with Interlink (TM) Injection Site, Baxter Healthcare Corp (1991) Summary page 2.
- K924064: Interlink Universal Vial Adapter, Baxter Healthcare Corp (1993) Summary page 2.

## Indications for use
The proposed adapter will be used to convert a conventional needle-accessed y-injection site on a Baxter or competitive solution administration set to an InterLink® injection site. This device, like other products containing the InterLink® injection site is designed to reduce the risk of accidental needle sticks when used in conjunction with the InterLink® cannula, as part of a “needleless” IV access system.

Source page: https://510kreport.com/device/K962893
Methodology: https://510kreport.com/methodology