# K113429: Safetouch PSV Winged Infusion Set, and Set with Filter

- Pathway: 510(k) (Special)
- Applicant: Nipro Medical Corporation
- Decided: Mar 12, 2012 after 112 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K132153: Safetouch PSV Winged Infusion Set with/Without Filter (2013), 0 descendants of its own

## Indications for use
The SafeTouch PSV Winged Infusion Set with/without filter 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 accidental needlesticks.

Source page: https://510kreport.com/device/K113429
Methodology: https://510kreport.com/methodology