# K960661: Maxcess Needle Free Connector (8200)

- Pathway: 510(k) (Traditional)
- Applicant: Solopak Medical Products, Inc.
- Decided: Mar 21, 1996 after 34 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 K915571 (1992). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915571: Clave Connector, Icu Medical, Inc. (1992) Summary page 1.

## Most influential descendants
- K970800: Maxcess Needlefree - Y- Site (100713) (1997), 1 descendant of its own
- K982170: Fluidsense Fluid Delivery System (1998), 0 descendants of its own
- K981548: NFC Needlefree Connector Model 69900 (1998), 0 descendants of its own
- K981547: NFC Needlefree Y-Site, Model 69970 (1998), 0 descendants of its own

## Indications for use
The Douglas Medical Products Maxcess Needlefree Connector is intended to be used as a needleless injection port that can be attached to a Luer Lock connector. It is intended for single patient use and 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/K960661
Methodology: https://510kreport.com/methodology