# K033515: Huberpro Safety Huber Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Command Medical Products
- Decided: Jan 22, 2004 after 77 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: 3 generations back to K890127 (1989). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013871: Lifeguard Safety Infusion Set, Horizon Medical Products, Inc. (2002) Summary page 1.
- K950597: Core-Resistant Huber Infusion Set with Y-Site, Distronic Sterile Products, Inc. (1995) Summary page 1.

## Most influential descendants
- K083482: Cook Vascular Vital-Ject Power Injectable Safety Infusion Set (2009), 0 descendants of its own

## Indications for use
The HuberPRO TM Safety Huber Infusion Set is intended to be used to administer solutions and medications into vascular implant ports. In addition, to minimize the risk of accidental needle stick injury after use, the attached safety guard fully encapulatep the needle when manually activated during withdrawal.

Source page: https://510kreport.com/device/K033515
Methodology: https://510kreport.com/methodology