# K002813: Nipro Safetouch Safety Fistula Needle

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corp.
- Decided: Nov 21, 2000 after 74 days
- Product code: FIE (Needle, Fistula)
- Device class: 2
- Regulation: 21 CFR 876.5540
- 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.
3 later devices descend from it; 1 cites 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
- K032777: Modification to: Nipro Safe Touch Safety Fistula Needle (2003), 2 descendants of its own
- K093985: Nipro Safetouch Locktail Safety Fistula Needle (2010), 0 descendants of its own
- K063721: Nipro Safetouch II Gamma (2007), 0 descendants of its own

## Recalls of this device
- Nov 8, 2002 · Not classified · Z-0408-03: Air or fluid leakage at the hub/needle junction.

Source page: https://510kreport.com/device/K002813
Methodology: https://510kreport.com/methodology