# K232234: Nouvo Safety Set

- Pathway: 510(k) (Traditional)
- Applicant: Poly Medicure Limited
- Decided: Mar 15, 2024 after 232 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: 8 generations back to K942988 (1995). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183399: BD Nexiva Closed IV Catheter System, Becton Dickinson Infusion Therapy Systems, Inc. (2019) Summary page 5.

## Indications for use
The Nouvo Safety Set IV Catheter are indicated for insertion into a patient's vascular system to sample blood, Infusion of fluids such as solutions, parenteral nutrition and administration of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. The 18G-22G catheters may be used intravascularly with power injectors at a maximum pressure of 300 psi.

Source page: https://510kreport.com/device/K232234
Methodology: https://510kreport.com/methodology