510(k) · Cleared
Recalled · Class II · 2022BD 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 Mar 20, 2019 as substantially equivalent to K170336 (Becton, Dickinson and Company, 2017) and 1 other predicate after a 103-day review. Its family tree reaches back 7 generations to 1995. 5 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 20, 2019
- Review
- 103 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 7 generations to K942988 (1995). 21 ancestors in all, the oldest K950301 (1995). 5 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- 6 generations backK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996 · Recalled
- 5 generations backK973167 Positive Pressure ConnectorIcu Medical, Inc. · 1997
- 4 generations backK021692 CLC2000 Catheter Patency DeviceIcu Medical, Inc. · 2003
- 3 generations backK100434 Clave NeutronIcu Medical, Inc. · 2010 · Recalled
- 2 generations backK132413 MZ1000Care Fusion · 2013
- 1 generation backK170336 BD Nexiva Closed IV Catheter System (Single Port) with MaxZero…Becton, Dickinson and Company · 2017
- This deviceK183399 BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK243403 BD Nexiva™ Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK261041 ClearSafe Closed SystemMedSource Labs, LLC · 2026
- Descendant · cites it directly · 0 of its ownK232234 Nouvo Safety SetPoly Medicure Limited · 2024
- Descendant · cites it directly · 0 of its ownK231239 Nexiva™ Closed IV Catheter System with NearPort™ IV AccessBecton Dickinson Infusion Therapy Systems, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK202060 Disposable IV catheterShinva Ande Healthcare Apparatus Co., Ltd. · 2021
Most influential descendants
Showing 5 of 5 · See all- K243403BD Nexiva™ Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2025 · cites it directly1descendant
- K261041ClearSafe Closed SystemMedSource Labs, LLC · 2026 · 2 generations on0descendants
- K232234Nouvo Safety SetPoly Medicure Limited · 2024 · cites it directly0descendants
- K231239Nexiva™ Closed IV Catheter System with NearPort™ IV AccessBecton Dickinson Infusion Therapy Systems, Inc. · 2023 · cites it directly0descendants
- K202060Disposable IV catheterShinva Ande Healthcare Apparatus Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K942988 | Filtered Extension Sets | B. Braun of America, Inc. | 1995 | 32 |
| −6 | K955585 | V2 Injection Site | B.Braun Medical, Inc. | 1996 | 27 |
| −5 | K973167 | Positive Pressure Connector | Icu Medical, Inc. | 1997 | — |
| −4 | K021692 | CLC2000 Catheter Patency Device | Icu Medical, Inc. | 2003 | — |
| −3 | K100434 | Clave Neutron | Icu Medical, Inc. | 2010 | 3 |
| −2 | K132413 | MZ1000 | Care Fusion | 2013 | — |
| −1 | K170336 | BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless… | Becton, Dickinson and Company | 2017 | — |
| 0 (this device) | K183399 | BD Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2019 | — |
| +1 | K243403 | BD Nexiva™ Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2025 | — |
| +2 | K261041 | ClearSafe Closed System | MedSource Labs, LLC | 2026 | — |
| +1 | K232234 | Nouvo Safety Set | Poly Medicure Limited | 2024 | — |
| +1 | K231239 | Nexiva™ Closed IV Catheter System with NearPort™ IV Access | Becton Dickinson Infusion Therapy Systems, Inc. | 2023 | — |
| +1 | K202060 | Disposable IV catheter | Shinva Ande Healthcare Apparatus Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K170336 | BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless ConnectorSummary page 4…BD Nexiva™ Closed IV Catheter System - Single Port Device 1 with MaxZero™ Needleless Connector 510(k) Reference: K170336 Common Name: Peripheral Intravascular or IV Catheter Regulation Number: 21 CFR… | 2017 |
| * | K161777 | BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsSummary page 4…Classification Panel: General Hospital Predicate Trade Name: BD Nexiva™ Closed IV Catheter System Device 2 510(k) Reference: K161777 Common Name: Peripheral Intravascular or IV Catheter Regulation Number: 21 CFR… | 2016 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 12, 2022 | Class II | Z-0174-2023 | Storage | During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed). |
| Sep 8, 2021 | Class II | Z-0306-2022 | Packaging process control | There is a breach in the product packaging that renders the product non-sterile. |
| Sep 14, 2020 | Class II | Z-0125-2021 | Nonconforming Material/Component | Dull/blunt needles within the IV Catheter System may lead to missed insertion attempts and delay in diagnosis or treatment until a new needle is inserted |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 10 of the 21 ancestors have a recall of any class.
- Of its descendants, K243403 (Becton Dickinson Infusion Therapy Systems, Inc., 2025) has gone furthest, with 1 descendant 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. 2019, 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?
BD Nexiva closed IV catheter systems are intended to be inserted into a patient’s peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183399 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183399: BD 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/K183399
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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