# K063721: Nipro Safetouch II Gamma

- Pathway: 510(k) (Special)
- Applicant: Nipro Medical Corp.
- Decided: Jan 12, 2007 after 28 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
Longest line of descent: 2 generations back to K002813 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032777: Modification to: Nipro Safe Touch Safety Fistula Needle, Nipro Medical Corp. (2003) Summary page 1.

## Indications for use
The NIPRO® Safetouch II Gamma 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 active sharps safety feature 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/K063721
Methodology: https://510kreport.com/methodology