# K895770: Exel Huber Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Exel Intl.
- Decided: Jul 19, 1990 after 296 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K113471: Nipro Huber Infusion Set, Excel Huber Infusion Set (2012), 0 descendants of its own
- K971582: Nipro Coreless Needle/Coreless Needle Set (1997), 0 descendants of its own

## Recalls of this device
- Dec 23, 2009 · Not classified · Z-0640-2010: Coring of port's septum, which may lead to: Decreased effectiveness of port, infection, necrosis, swelling, and embolization, which may result in Pulmonary Embolism, Limb ischemia, stroke, local extra

Source page: https://510kreport.com/device/K895770
Methodology: https://510kreport.com/methodology