# K011858: Interlink Threaded Lock Cannula

- Pathway: 510(k) (Special)
- Applicant: Bd
- Decided: Jun 19, 2001 after 5 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 K911868 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911868: Interlink (TM) Blunt Cannula, Modification, Baxter Healthcare Corp (1991) Summary page 1.
- (no number) InterLink® Threaded Lock Cannula: named in the summary without a submission number

## Indications for use
The Threaded Lock Cannula is one of several needleless cannula components that are part of the InterLink® IV Access System that providc for continuous and intcrmittent IV Therapy, Vial Access, and Blood Draws. The system allows the user to make connections to any IV line using a mating injection site with a pre-slit septum safely without chance of needle stick injury to the user or paticnt. InterLink® Threaded T.ock Cannula are specifically designed for use with InterLink® injection sites, identified by a white alert ring around the septum. Not compatible with conventional injection sites.

Source page: https://510kreport.com/device/K011858
Methodology: https://510kreport.com/methodology