# K132153: Safetouch PSV Winged Infusion Set with/Without Filter

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corporation
- Decided: Dec 5, 2013 after 146 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: 2 generations back to K011297 (2001). 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)
- K113429: Safetouch PSV Winged Infusion Set, and Set with Filter, Nipro Medical Corporation (2012) Summary page 1.

## 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. 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/K132153
Methodology: https://510kreport.com/methodology