510(k) · Cleared
Recalled · Class II · 2019BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
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 Aug 29, 2016 as substantially equivalent to K102520 (Becton Dickinson Infusion Therapy Systems, Inc., 2011) and 1 other predicate after a 61-day review. Its family tree reaches back 4 generations to 2004. 11 later devices descend from it. It has been recalled once.
- Decided
- Aug 29, 2016
- Review
- 61 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K032843 (2004). 5 ancestors in all, the oldest K950301 (1995). 11 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK032843 Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2004 · Recalled
- 3 generations backK102520 BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2011
- 2 generations backK111366 BD Nexiva Diffusics Closed IV Catheter SystemBecton, Dickinson and Company (BD) · 2011
- 1 generation backK123734 BD Nexiva Diffusics Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2013
- This deviceK161777 BD Nexiva and BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. · 2016
- Descendant · cites it directly · 6 of its ownK170336 BD Nexiva Closed IV Catheter System (Single Port) with MaxZero…Becton, Dickinson and Company · 2017
- Descendant · cites it directly · 5 of its ownK183399 BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · Recalled
- Descendant · cites it directly · 3 of its ownK170283 BD Nexiva Diffusics Closed IV Catheter SystemBecton, Dickinson and Company · 2017
- Descendant · 2 generations on · 2 of its ownK173354 BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK243403 BD Nexiva™ Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless ConnectorBecton, Dickinson and Company · 2017 · cites it directly6descendants
- K183399BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · cites it directly5descendants
- K170283BD Nexiva Diffusics Closed IV Catheter SystemBecton, Dickinson and Company · 2017 · cites it directly3descendants
- K173354BD Nexiva Diffusics Closed IV Catheter SystemsBecton Dickinson Infusion Therapy Systems, Inc. · 2017 · 2 generations on2descendants
- K243403BD Nexiva™ Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K032843 | Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2004 | 17 |
| −3 | K102520 | BD Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2011 | — |
| −2 | K111366 | BD Nexiva Diffusics Closed IV Catheter System | Becton, Dickinson and Company (BD) | 2011 | — |
| −1 | K123734 | BD Nexiva Diffusics Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2013 | — |
| 0 (this device) | K161777 | BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems | Becton Dickinson Infusion Therapy Systems, Inc. | 2016 | — |
| +1 | K170336 | BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless… | Becton, Dickinson and Company | 2017 | — |
| +1 | K183399 | BD Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2019 | 3 |
| +1 | K170283 | BD Nexiva Diffusics Closed IV Catheter System | Becton, Dickinson and Company | 2017 | — |
| +2 | K173354 | BD Nexiva Diffusics Closed IV Catheter Systems | Becton Dickinson Infusion Therapy Systems, Inc. | 2017 | — |
| +2 | K243403 | BD Nexiva™ Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K102520 | BD Nexiva Closed IV Catheter SystemSummary page 5…Classification Panel: General Hospital Predicate Trade Name: BD Nexiva™ Closed IV Catheter System Device 510(k) Reference: K102520 (BD Nexiva) Common Name: Peripheral Intravascular or IV Catheter Regulation Number: 21 CF… | 2011 |
| * | K123734 | BD Nexiva Diffusics Closed IV Catheter SystemSummary page 5…sification Panel: General Hospital Predicate Trade Name: BD Nexiva™ Diffusics™ Closed IV Catheter System Device 510(k) Reference: K123734 (BD Nexiva Common Name: Peripheral Intravascular or IV Catheter Diffusics) Regulation Number: 21 CF… | 2013 |
What descends from it? (11)
See all 113 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 |
|---|---|---|---|---|
| Mar 1, 2019 | Class II | Z-1710-2019 | Release of Material/Component prior to receiving test results | Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K170336 (Becton, Dickinson and Company, 2017) has gone furthest, with 6 descendants of its own.
- 6 other devices also cite its predicate K102520.
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. 2016, 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 vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These catheters 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 22-18GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum…
Read the full statement (178 words)
BD Nexiva closed IV catheter systems are intended to be inserted into a patient’s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These catheters 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 22-18GA (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.
BD Nexiva Diffusics closed IV catheter systems are intended to be inserted into a patient’s 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. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa) when access ports not suitable for use with power injectors are removed.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161777 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161777: BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161777
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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