# K112073: Infusite Needleless Acces Device (Sterile, Bulk Non-Sterile) and Infusite Needleless Access Device 'Y' Adapter (Bulk...

- Pathway: 510(k) (Traditional)
- Applicant: Rx Devices, LLC
- Decided: Apr 11, 2012 after 266 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: 3 generations back to K901063 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960280: Ivac Needle Free Valve Administration Sets, Y (1996) Summary page 1.
- K002689: Swabsite Swabbable Valve, Model 245000, Quest Medical, Inc. (2001) Summary page 1.

## Indications for use
The InfuSite Needleless Access Device is a closed system needleless accessory, which permits blood sampling, intermittent injection or infusion of fluids or medications when connected exclusively to luer systems.,

Source page: https://510kreport.com/device/K112073
Methodology: https://510kreport.com/methodology