# K172506: BD Cathena Safety IV Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Sep 17, 2017 after 30 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: 5 generations back to K854773 (1986). 19 ancestors in all.
4 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)
- K110443: BD Insyte Autoguard BC, Becton, Dickinson & CO (2011) Summary page 4.
- K111236: Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1, B.Braun Melsungen AG (2011) Summary page 4.

## Most influential descendants
- K192493: BD Cathena (TM) Safety IV Catheter (2020), 3 descendants of its own
- 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 catheters 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. The catheters are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa).

Source page: https://510kreport.com/device/K172506
Methodology: https://510kreport.com/methodology