510(k) · Cleared
ClearedBD Intima II PLUS Closed IV Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Aug 17, 2017 as substantially equivalent to K143610 (Becton Dickinson Infusion Therapy Systems, Inc., 2015) after a 27-day review. Its family tree reaches back 3 generations to 1983. 1 later device descends from it.
- Decided
- Aug 17, 2017
- Review
- 27 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K833657 (1983). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK833657 Angio-Set Intravenous Cath. SetDeseret Medical, Inc. · 1983
- 2 generations backK100775 BD Intima II Closed IV CatheterBecton Dickinson Infusion Therapy Systems, Inc. · 2010
- 1 generation backK143610 BD Intima II Closed IV CatheterBecton Dickinson Infusion Therapy Systems, Inc. · 2015
- This deviceK172204 BD Intima II PLUS Closed IV Catheter SystemBecton, Dickinson and Company · 2017
- Descendant · cites it directly · 0 of its ownK200891 BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV…Becton, Dickinson and Company · 2021
Most influential descendants
Showing 1 of 1 · See all- K200891BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter SystemBecton, Dickinson and Company · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K833657 | Angio-Set Intravenous Cath. Set | Deseret Medical, Inc. | 1983 | — |
| −2 | K100775 | BD Intima II Closed IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2010 | — |
| −1 | K143610 | BD Intima II Closed IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2015 | — |
| 0 (this device) | K172204 | BD Intima II PLUS Closed IV Catheter System | Becton, Dickinson and Company | 2017 | — |
| +1 | K200891 | BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter… | Becton, Dickinson and Company | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K143610 | BD Intima II Closed IV CatheterSummary page 4…lassification Panel: General Hospital Predicate Trade Name: BD Intima IITM Closed IV Catheter System Device 510(k) Reference: K143610 Common Name: Peripheral Intravascular or IV Catheter Regulation Number: 21… | 2015 |
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 |
|---|---|---|---|
| K200891 | BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System | 2021 | 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?
- The line of descent spans 34 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K200891 (Becton, Dickinson and Company, 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K143610.
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. 2017, 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?
The BD Intima II PLUS™ Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172204: BD Intima II PLUS 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/K172204
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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