# K955182: Nipro Arterial Venous Fistula Needle

- Pathway: 510(k) (Traditional)
- Applicant: Nissho Corp.
- Decided: Jun 4, 1996 after 204 days
- Product code: FIE (Needle, Fistula)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 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
- K071145: Nipro Safetouch Tulip Safety Fistula Needle (2007), 3 descendants of its own
- K163025: DORA Disposable A.V. Fistula Needle Sets (2017), 1 descendant of its own
- K213015: DORA Disposable A.V. Fistula Needle Sets (2022), 0 descendants of its own
- K171505: Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) (2018), 0 descendants of its own
- K063368: Nipro Biohole Needle (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K955182
Methodology: https://510kreport.com/methodology