# K960051: Nipro Safelet Cath

- Pathway: 510(k) (Traditional)
- Applicant: Nissho Corp.
- Decided: Mar 28, 1996 after 84 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 K895768 (1990). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895768: Exel Safelet Catheter, Exel Intl. (1990) Summary page 1.

## Most influential descendants
- K022756: Nipro Bio-Flex Catheter (2002), 0 descendants of its own
- K013287: Nipro Safelet Cath (2001), 0 descendants of its own

## Indications for use
The Nipro Safelet Cath is intended to be inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously.

Source page: https://510kreport.com/device/K960051
Methodology: https://510kreport.com/methodology