# K140136: Nipro Safetouch PSV Scalp Vein Set with Safety Device

- Pathway: 510(k) (Special)
- Applicant: Nipro Medical Corporation
- Decided: Feb 14, 2014 after 28 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011297 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011297: Nipro Safetouch Scalp Vein and Blood Collection Set, Nipro Medical Corp. (2001) Summary page 1.

## Indications for use
The Nipro SafeTouch PSV Scalp Vein Set with Safety Device is intended to be used for insertion into a patient's vascular system (for single use) as an indwelling device to administer fluids intravenously or to sample blood. Secondly, it is designed with an active sharp feature that requires physical action by the clinician to prevent needlestick incidents.

Source page: https://510kreport.com/device/K140136
Methodology: https://510kreport.com/methodology