# K093985: Nipro Safetouch Locktail Safety Fistula Needle

- Pathway: 510(k) (Special)
- Applicant: Nipro Medical Corp.
- Decided: Jan 22, 2010 after 29 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 LOCKTAILTM is intended for use as a blood access device for blood purification and for other treatments requiring extracorporeal circuit. The Nipro SafeTouch LoCKTAIL Tm 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/K093985
Methodology: https://510kreport.com/methodology