# K981548: NFC Needlefree Connector Model 69900

- 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: 2 generations back to K915571 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.
- K915571: Clave Connector, Icu Medical, Inc. (1992) Summary page 1.

## Indications for use
This device is intended to be used as a needless injection port that can be attached to any standard luer connector. It is a single patient use device that has an access port that can be swabbed and accessed multiple times.

Source page: https://510kreport.com/device/K981548
Methodology: https://510kreport.com/methodology