# K041179: Modification to the Nac Plus Needleless Access Connector

- Pathway: 510(k) (Special)
- Applicant: Medegen Medical Manufacturing Services, Inc.
- Decided: Jun 4, 2004 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The NACTM PLUS Needleless Access Connector is an accessory to an Intravascular Administration Set used as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein or artery.

Source page: https://510kreport.com/device/K041179
Methodology: https://510kreport.com/methodology