# K071145: Nipro Safetouch Tulip Safety Fistula Needle

- Pathway: 510(k) (Abbreviated)
- Applicant: Nipro Medical Corporation
- Decided: Sep 7, 2007 after 136 days
- Product code: MPB (Catheter, Hemodialysis, Non-Implanted)
- 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
Longest line of descent: 1 generation back to K932074 (1994). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932074: Medisystems Apheresis Needle with Guard, Medisystems Corp. (1994) Summary page 1.
- K955182: Nipro Arterial Venous Fistula Needle, Nissho Corp. (1996) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Aug 13, 2015 · Class II · Z-0161-2016: Some 1 1/4" needles were packaged and labeled in the 1" blister package.

## Indications for use
The NIPRO SafeTouch TULIP TM Safety Fistula Needle is intended for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood. Secondly, it is designed with an anti-stick needle protector requiring physical action by the clinician to aid in the prevention of accidental needlesticks. The compatibility of available configurations is the responsibility of the physician in charge.

Source page: https://510kreport.com/device/K071145
Methodology: https://510kreport.com/methodology