# K895769: Exel Huber Needle

- Pathway: 510(k) (Traditional)
- Applicant: Exel Intl.
- Decided: Feb 16, 1990 after 143 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- 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
- K113469: Nipro Huber Infusion, Excel Huber Needle (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-0638-2010: Non-coring needles that, when inserted into an implanted port, were shown to core the silicone port's septum. Coring of port's septum may lead to: decreased effectiveness of port, infection, necrosis,

Source page: https://510kreport.com/device/K895769
Methodology: https://510kreport.com/methodology