# K120548: Hlic Needle-Less Valve

- Pathway: 510(k) (Traditional)
- Applicant: Health Line International Corporation
- Decided: May 4, 2012 after 71 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)
- K002689: Swabsite Swabbable Valve, Model 245000, Quest Medical, Inc. (2001) Summary page 3.

## Indications for use
The HLIC Needle-Less Valve is intended to allow access to IV administration sets, medication vials, blood donor collection bags, and solution bags with one convenient device without the use of needles or blunt cannulas.

Source page: https://510kreport.com/device/K120548
Methodology: https://510kreport.com/methodology