510(k) · Cleared
Recalled · Class II · 2025BD Cathena Safety IV Catheter
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 31, 2022 as substantially equivalent to K201717 (Becton Dickinson Infusion Therapy Systems, Inc., 2020) after a 30-day review. Its family tree reaches back 8 generations to 1986. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Mar 31, 2022
- Review
- 30 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 8 generations to K854773 (1986). 22 ancestors in all, the oldest K801941 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK854773 Supercath a.V. FistulaTogo Medikit Co., Ltd. · 1986
- 7 generations backK050114 Supercath Z3VTogo Medikit Co., Ltd. · 2005
- 6 generations backK081953 Supercath 5Togo Medikit Co., Ltd. · 2009
- 5 generations backK093546 Supercath 5 Model SP120-XX-XX, SP125-XX-XXTogo Medikit Co., Ltd. · 2009
- 4 generations backK110443 BD Insyte Autoguard BCBecton, Dickinson & CO · 2011
- 3 generations backK172506 BD Cathena Safety IV CatheterBecton, Dickinson and Company · 2017
- 2 generations backK192493 BD Cathena (TM) Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc. · 2020
- 1 generation backK201717 BD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc. · 2020
- This deviceK220584 BD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK251155 BD Cathena™ Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251155BD Cathena™ Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K854773 | Supercath a.V. Fistula | Togo Medikit Co., Ltd. | 1986 | — |
| −7 | K050114 | Supercath Z3V | Togo Medikit Co., Ltd. | 2005 | — |
| −6 | K081953 | Supercath 5 | Togo Medikit Co., Ltd. | 2009 | — |
| −5 | K093546 | Supercath 5 Model SP120-XX-XX, SP125-XX-XX | Togo Medikit Co., Ltd. | 2009 | — |
| −4 | K110443 | BD Insyte Autoguard BC | Becton, Dickinson & CO | 2011 | — |
| −3 | K172506 | BD Cathena Safety IV Catheter | Becton, Dickinson and Company | 2017 | — |
| −2 | K192493 | BD Cathena (TM) Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2020 | — |
| −1 | K201717 | BD Cathena Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2020 | — |
| 0 (this device) | K220584 | BD Cathena Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2022 | — |
| +1 | K251155 | BD Cathena™ Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 2 | 0 |
| 1986 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K201717 | BD Cathena Safety IV CatheterSummary page 4…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K201717 BD CathenaT Safety IV Catheter ZFOZ LDevice Descriptio… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251155 | BD Cathena™ Safety IV Catheter | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2025 | Class II | Z-1808-2025 | Process control | Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in… |
| Aug 29, 2023 | Class II | Z-0025-2024 | Process change control | There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the needle safety shield leaving the contaminated needle point exposed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 6 of the 22 ancestors have a recall of any class.
- Of its descendants, K251155 (Becton Dickinson Infusion Therapy Systems, Inc., 2025) has gone furthest, with 0 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. 2022, 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 Cathena™ Safety IV Catheters 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. These devices are suitable for use with power injectors set to a maximum pressure of 325 psi (2240 kPa).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220584 · printed Nov 5, 2026
Cite this page
510(k) Report. “K220584: BD Cathena Safety IV Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K220584
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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