# K950597: Core-Resistant Huber Infusion Set with Y-Site

- Pathway: 510(k) (Traditional)
- Applicant: Distronic Sterile Products, Inc.
- Decided: Jul 26, 1995 after 167 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033515: Huberpro Safety Huber Infusion Set (2004), 1 descendant of its own
- K083482: Cook Vascular Vital-Ject Power Injectable Safety Infusion Set (2009), 0 descendants of its own
- K961495: Huber Needle Extension Set with Standard Y-Injection Site, Interlink Y-Injection Site, Interlink T-Injection Site (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K950597
Methodology: https://510kreport.com/methodology