# K111366: BD Nexiva Diffusics Closed IV Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company (BD)
- Decided: Sep 30, 2011 after 137 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 K032843 (2004). 3 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102520: BD Nexiva Closed IV Catheter System, Becton Dickinson Infusion Therapy Systems, Inc. (2011) Summary page 1.
- K032843: Nexiva Closed IV Catheter System, Becton Dickinson Infusion Therapy Systems, Inc. (2004) Summary page 1.
- K950301: Angiocath (R) Nonvalon (R) and Angio-Set (R) IV Catheters, Becton Dickinson Vascular Access, Inc. (1995) Summary page 1.

## Most influential descendants
- K123734: BD Nexiva Diffusics Closed IV Catheter System (2013), 12 descendants of its own
- K161777: BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems (2016), 11 descendants of its own
- K170336: BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector (2017), 6 descendants of its own
- K183399: BD Nexiva Closed IV Catheter System (2019), 5 descendants of its own
- K170283: BD Nexiva Diffusics Closed IV Catheter System (2017), 3 descendants of its own

## Indications for use
The BD Nexiva™ Diffusics™ intravascular catheter is inserted into a patients vascular system to sample blood, monitor blood pressure or administer fluids. The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.

Source page: https://510kreport.com/device/K111366
Methodology: https://510kreport.com/methodology