510(k) · Cleared
ClearedBD Nexiva 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 Jan 6, 2011 as substantially equivalent to K032843 (Becton Dickinson Infusion Therapy Systems, Inc., 2004) after a 126-day review. Its family tree reaches back 1 generation to 2004. 40 later devices descend from it.
- Decided
- Jan 6, 2011
- Review
- 126 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032843 (2004). 40 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK032843 Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2004 · Recalled
- This deviceK102520 BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2011
- Descendant · cites it directly · 19 of its ownK121073 Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · Recalled
- Descendant · cites it directly · 13 of its ownK111366 BD Nexiva Diffusics Closed IV Catheter SystemBecton, Dickinson and Company (BD) · 2011
- Descendant · 2 generations on · 12 of its ownK133856 Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 12 of its ownK123734 BD Nexiva Diffusics Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2013
- Descendant · cites it directly · 11 of its ownK161777 BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. · 2016 · Recalled
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K121073Powerglide Midline CatheterC.R. Bard, Inc. · 2012 · cites it directly19descendants
- K111366BD Nexiva Diffusics Closed IV Catheter SystemBecton, Dickinson and Company (BD) · 2011 · cites it directly13descendants
- K133856Powerglide Midline CatheterC.R. Bard, Inc. · 2014 · 2 generations on12descendants
- K123734BD Nexiva Diffusics Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2013 · 2 generations on12descendants
- K161777BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. · 2016 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032843 | Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2004 | 17 |
| 0 (this device) | K102520 | BD Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2011 | — |
| +1 | K121073 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2012 | 1 |
| +1 | K111366 | BD Nexiva Diffusics Closed IV Catheter System | Becton, Dickinson and Company (BD) | 2011 | — |
| +2 | K133856 | Powerglide Midline Catheter | C.R. Bard, Inc. | 2014 | 1 |
| +2 | K123734 | BD Nexiva Diffusics Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2013 | — |
| +1 | K161777 | BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems | Becton Dickinson Infusion Therapy Systems, Inc. | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 7 | 0 |
| 2026 | 1 | 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.
Planning a device in FOZ? 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? (1)
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 |
|---|---|---|---|
| * | K032843 | Nexiva Closed IV Catheter SystemSummary page 1…Intravascular Catheter Classification Name: Intravascular Catheter (FOZ) 880.5200 Unmodified/Predicate Device: (K032843) BID NexivaTM Closed IV Catheter System Description of the device: The BID NexivaM Closed IV Catheter System consists of an ove… | 2004 |
What descends from it? (40)
See all 407 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121073 | Powerglide Midline Catheter | 2012 | 19 |
| K111366 | BD Nexiva Diffusics Closed IV Catheter System | 2011 | 13 |
| K161777 | BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems | 2016 | 11 |
| K231626 | OSPREY Closed IV Catheter System (OspreyV2) | 2023 | 1 |
| K171530 | Deltaven XiV Max, Deltaven XiV Max FF | 2017 | 1 |
| K252398 | SURFLO Hybria Closed System Safety IV Catheter | 2025 | 0 |
| K121488 | JMS Safe Wing Cath (SWC) | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2011, this device’s year, is highlighted.
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?
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.…
Read the full statement (121 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102520: BD Nexiva Closed IV Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102520
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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