# K220584: BD Cathena Safety IV Catheter

- Pathway: 510(k) (Special)
- Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
- Decided: Mar 31, 2022 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K854773 (1986). 22 ancestors in all.
1 later device descends 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)
- K201717: BD Cathena Safety IV Catheter, Becton Dickinson Infusion Therapy Systems, Inc. (2020) Summary page 4.

## Most influential descendants
- K251155: BD Cathena™ Safety IV Catheter (2025), 0 descendants of its own

## Recalls of this device
- Apr 21, 2025 · Class II · Z-1808-2025: Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV 
- Aug 29, 2023 · Class II · Z-0025-2024: There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the needle safety shield leaving the contaminat

## 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/K220584
Methodology: https://510kreport.com/methodology