# K161681: Nipro SafeTouch IV Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corporation
- Decided: Mar 8, 2017 after 264 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: 3 generations back to K801941 (1980). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020785: Introcan Safety IV Catheter, B.Braun Medical, Inc. (2002) Summary page 5.

## Indications for use
The Nipro SafeTouch IV Catheter is a passive anti-needle stick intra-vascular catheter that is inserted into the patient's vascular system for short term use (less than 30 days) for the infusion of fluids, and/or blood components. 16-24 gauge catheters may be used with power injectors for which the maximum pressure setting is 300psi

Source page: https://510kreport.com/device/K161681
Methodology: https://510kreport.com/methodology