# K192493: BD Cathena (TM) Safety IV Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
- Decided: Jan 24, 2020 after 135 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: 6 generations back to K854773 (1986). 20 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172506: BD Cathena Safety IV Catheter, Becton, Dickinson and Company (2017) Summary page 4.

## Most influential descendants
- K201717: BD Cathena Safety IV Catheter (2020), 2 descendants of its own
- K220584: BD Cathena Safety IV Catheter (2022), 1 descendant of its own
- K251155: BD Cathena™ Safety IV Catheter (2025), 0 descendants of its own

## Indications for use
BD Cathena™ Safety IV Catheters are intended to be inserted into a patient’s peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa).

Source page: https://510kreport.com/device/K192493
Methodology: https://510kreport.com/methodology