# K041844: All Safe Huber Safety Infusion Sets

- Pathway: 510(k) (Traditional)
- Applicant: Nexus Medical, LLC
- Decided: Sep 3, 2004 after 57 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 AllSafe™ Huber Safety Infusion Sets are used to access surgically implanted vascular ports for the administration of fluids and withdrawal of blood. The AllSafe Huber Safety Infusion Sets facilitate the safe removal of the needle and may aid in the prevention of needle stick injuries.

Source page: https://510kreport.com/device/K041844
Methodology: https://510kreport.com/methodology