# K981547: NFC Needlefree Y-Site, Model 69970

- Pathway: 510(k) (Traditional)
- Applicant: Filtertek, Inc.
- Decided: Jun 18, 1998 after 49 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 K915571 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970800: Maxcess Needlefree - Y- Site (100713), Solopak Medical Products, Inc. (1997) Summary page 1.

## Indications for use
The NFC Y-Site is for single patient use and intended for placement between the male Luer connection of a primary solution source and the patient's vascular access device. In this position, the y-site body provides unobstructed flow between the fluid source and the patient. The Needlefree side port of the y-site is swabbable and can be accessed multiple times using a male Luer for the purpose of administering general IV solutions or blood.

Source page: https://510kreport.com/device/K981547
Methodology: https://510kreport.com/methodology