# K102520: BD Nexiva Closed IV Catheter System

- Pathway: 510(k) (Special)
- Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
- Decided: Jan 6, 2011 after 126 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: 1 generation back to K032843 (2004). 1 ancestor in all.
40 later devices descend from it; 7 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032843: Nexiva Closed IV Catheter System, Becton Dickinson Infusion Therapy Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- K121073: Powerglide Midline Catheter (2012), 19 descendants of its own
- K111366: BD Nexiva Diffusics Closed IV Catheter System (2011), 13 descendants of its own
- K133856: Powerglide Midline Catheter (2014), 12 descendants of its own
- 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

## Indications for use
As indicated in 21 CFR Part 880.5200, The NexivaTM intravascular catheter is inserted into a patient's vascular system for a short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature and luer access port, aid in the prevention of needle-stick injuries. Blood is contained within the device during the catheter insertion process aiding in the prevention of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The 18-22 gauge NexivaTM catheters are suitable for use with power injectors rated for a maximum of 300 psi when the luer access port(s) is removed and a direct connection is made.

Source page: https://510kreport.com/device/K102520
Methodology: https://510kreport.com/methodology