# K032777: Modification to: Nipro Safe Touch Safety Fistula Needle

- Pathway: 510(k) (Special)
- Applicant: Nipro Medical Corp.
- Decided: Nov 14, 2003 after 67 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002813 (2000). 1 ancestor in all.
2 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)
- K002813: Nipro Safetouch Safety Fistula Needle, Nipro Medical Corp. (2000)

## Most influential descendants
- 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
- Apr 1, 2014 · Class III · Z-0599-2016: Device has the potential to have torn wings.

## Indications for use
The Nipro SafeTouch Safety Fistula Needles is intended for use as a blood access device for blood purification and for other treatments requiring extracorporeal circuit. The Nipro SafeTouch Safety Fistula Needle aids in the prevention of accidental needle stick injuries. The compatibility of available configurations is the responsibility of the physician in charge.

Source page: https://510kreport.com/device/K032777
Methodology: https://510kreport.com/methodology