# K013287: Nipro Safelet Cath

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Medical Corp.
- Decided: Dec 3, 2001 after 62 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 K895768 (1990). 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)
- K960051: Nipro Safelet Cath, Nissho Corp. (1996) Summary page 1.

## Indications for use
The Nipro® Safelet Cath is intended to be inserted irlto a patient’s vascular system for short-term use to sample blood or administer fluids intravenously.

Source page: https://510kreport.com/device/K013287
Methodology: https://510kreport.com/methodology