# K970800: Maxcess Needlefree - Y- Site (100713)

- Pathway: 510(k) (Traditional)
- Applicant: Solopak Medical Products, Inc.
- Decided: Apr 2, 1997 after 29 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: 2 generations back to K915571 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960661: Maxcess Needle Free Connector (8200), Solopak Medical Products, Inc. (1996) Summary page 1.

## Most influential descendants
- K981547: NFC Needlefree Y-Site, Model 69970 (1998), 0 descendants of its own

## Indications for use
The Douglas Medical Products Maxcess™ NeedleFree Y-Site is intended 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 can be swabbed and then accessed multiple times within the limits of CDC guidelines and/or institutional guidelines. The closure system has been tested and has been found to maintain line patency throughout the labeled duration of use.

Source page: https://510kreport.com/device/K970800
Methodology: https://510kreport.com/methodology