510(k) · Cleared
Recalled · Class II · 2018Nexiva Closed IV Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson Infusion Therapy Systems, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Feb 27, 2004 after a 169-day review. The FDA summary names its predicate without a number. 1 of the 72 devices in its family, counting itself, has a Class I recall. 71 later devices descend from it. It has been recalled 17 times.
- Decided
- Feb 27, 2004
- Review
- 169 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 17
- Predicates
- 0
71 later devices descend from it, 8 citing it directly. 1 of the 72 devices in this family, counting this one, has a Class I recall.
- This deviceK032843 Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2004
- Descendant · cites it directly · 40 of its ownK102520 BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2011
- Descendant · 2 generations on · 19 of its ownK121073 Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · Recalled
- Descendant · cites it directly · 15 of its ownK111236 Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and…B.Braun Melsungen AG · 2011 · Recalled
- Descendant · cites it directly · 13 of its ownK111366 BD Nexiva Diffusics Closed IV Catheter SystemBecton, Dickinson and Company (BD) · 2011
- Descendant · 3 generations on · 12 of its ownK133856 Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · Recalled
Showing 5 of 71 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K163513 Arrow Endurance Extended Dwell Peripheral…2 generations on · 2017
Most influential descendants
Showing 5 of 71 · See all- K102520BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2011 · cites it directly40descendants
- K121073Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · 2 generations on19descendants
- K111236Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) /…B.Braun Melsungen AG · 2011 · cites it directly15descendants
- K111366BD Nexiva Diffusics Closed IV Catheter SystemBecton, Dickinson and Company (BD) · 2011 · cites it directly13descendants
- K133856Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032843 | Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2004 | — |
| +1 | K102520 | BD Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2011 | — |
| +2 | K121073 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2012 | 1 |
| +1 | K111236 | Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4… | B.Braun Melsungen AG | 2011 | 1 |
| +1 | K111366 | BD Nexiva Diffusics Closed IV Catheter System | Becton, Dickinson and Company (BD) | 2011 | — |
| +3 | K133856 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 8 | 1 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 9 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | BD Saf-T-Intima IVCatheter Named without a submission number | |
| * | — | B. Braun Introcan Safety IVCatheter Named without a submission number |
What descends from it? (71)
See all 718 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102520 | BD Nexiva Closed IV Catheter System | 2011 | 40 |
| K111236 | Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) /… | 2011 | 15 |
| K111366 | BD Nexiva Diffusics Closed IV Catheter System | 2011 | 13 |
| K151513 | Arrow Endurance Extended Dwell Peripheral Catheter System | 2015 | 4 |
| K082997 | Terumo Hybria Closed System Safety I.V. Catheter | 2009 | 4 |
| K120839 | Novacath Secure IV Catheter System-18G | 2012 | 1 |
| K111334 | Benelli Access Device | 2011 | 0 |
| K073471 | Vantagecath Intravascular Catheter | 2008 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 23, 2018 | Class II | Z-0384-2019 | Under Investigation by firm | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Other | The Y-luer connection may crack during normal product use. |
| Feb 3, 2005 | Not classified | Z-0585-05 | Other | The Y-luer connection may crack during normal product use. |
| Feb 3, 2005 | Not classified | Z-0586-05 | Other | The Y-luer connection may crack during normal product use. |
| Feb 3, 2005 | Not classified | Z-0587-05 | Other | The Y-luer connection may crack during normal product use. |
The 5 latest of 17 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K163513Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K102520 (Becton Dickinson Infusion Therapy Systems, Inc., 2011) has gone furthest, with 40 descendants of its own.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
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…
Read the full statement (113 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032843 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032843: Nexiva Closed IV Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032843
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026