# K222852: Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corporation
- Decided: May 25, 2023 after 246 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931367 (1993). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162081: BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle,  BD 1ml Luer-lok Insulin Syringe, Becton, Dickinson and Company (2016) Summary page 4.

## Indications for use
The Nipro SafeTouch Needle is indicated for general purpose injection and aspiration of fluid from vials, and to and from parts of the body below the surface of the skin. It includes a needle shield to prevent against accidental needlestick injuries. The needle is compatible with standard Luer-lock syringes. The Nipro Syringe with SafeTouch Needle is indicated for general purpose injection and aspiration of fluid from vials, and to and from parts of the body below the surface of the skin. It includes a needle shield to prevent against accidental needlestick injuries.

Source page: https://510kreport.com/device/K222852
Methodology: https://510kreport.com/methodology