# K032843: Nexiva Closed IV Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
- Decided: Feb 27, 2004 after 169 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: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
71 later devices descend from it; 8 cite it directly.
1 of 72 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BD Saf-T-Intima IVCatheter: named in the summary without a submission number
- (no number) B. Braun Introcan Safety IVCatheter: named in the summary without a submission number

## Most influential descendants
- K102520: BD Nexiva Closed IV Catheter System (2011), 40 descendants of its own
- K121073: Powerglide Midline Catheter (2012), 19 descendants of its own
- 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 (2011), 15 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

## Recalls of this device
- Aug 23, 2018 · Class II · Z-0384-2019: One lot of the specified needles is not performing as intended due to a failure in the needle tip shield/safety mechanism, which may lead to an increased risk of a contaminated needlestick injury.
- Oct 19, 2009 · Not classified · Z-0830-2010: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Oct 19, 2009 · Not classified · Z-0835-2010: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Oct 19, 2009 · Not classified · Z-0831-2010: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Oct 19, 2009 · Not classified · Z-0834-2010: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Oct 19, 2009 · Not classified · Z-0838-2010: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Oct 19, 2009 · Not classified · Z-0839-2010: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Oct 19, 2009 · Not classified · Z-0840-2010: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Oct 19, 2009 · Not classified · Z-0833-2010: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Oct 19, 2009 · Not classified · Z-0836-2010: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Oct 19, 2009 · Not classified · Z-0837-2010: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Oct 19, 2009 · Not classified · Z-0829-2010: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Oct 19, 2009 · Not classified · Z-0832-2010: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Feb 3, 2005 · Not classified · Z-0584-05: The Y-luer connection may crack during normal product use.
- Feb 3, 2005 · Not classified · Z-0585-05: The Y-luer connection may crack during normal product use.
- Feb 3, 2005 · Not classified · Z-0586-05: The Y-luer connection may crack during normal product use.
- Feb 3, 2005 · Not classified · Z-0587-05: The Y-luer connection may crack during normal product use.

## Indications for use
The NexivaTM intravascular catheter is inserted into a patient's vascular system for 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 needlestick 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 18-24 gauge Nexiva 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/K032843
Methodology: https://510kreport.com/methodology