510(k) · Cleared
ClearedNouvo Safety Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Poly Medicure Limited · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Mar 15, 2024 as substantially equivalent to K183399 (Becton Dickinson Infusion Therapy Systems, Inc., 2019) after a 232-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Mar 15, 2024
- Review
- 232 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K942988 (1995). 22 ancestors in all, the oldest K950301 (1995). No later device cites it as a predicate yet.
- Root · 8 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- 7 generations backK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996 · Recalled
- 6 generations backK973167 Positive Pressure ConnectorIcu Medical, Inc. · 1997
- 5 generations backK021692 CLC2000 Catheter Patency DeviceIcu Medical, Inc. · 2003
- 4 generations backK100434 Clave NeutronIcu Medical, Inc. · 2010 · Recalled
- 3 generations backK132413 MZ1000Care Fusion · 2013
- 2 generations backK170336 BD Nexiva Closed IV Catheter System (Single Port) with MaxZero…Becton, Dickinson and Company · 2017
- 1 generation backK183399 BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · Recalled
- This deviceK232234 Nouvo Safety SetPoly Medicure Limited · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K942988 | Filtered Extension Sets | B. Braun of America, Inc. | 1995 | 32 |
| −7 | K955585 | V2 Injection Site | B.Braun Medical, Inc. | 1996 | 27 |
| −6 | K973167 | Positive Pressure Connector | Icu Medical, Inc. | 1997 | — |
| −5 | K021692 | CLC2000 Catheter Patency Device | Icu Medical, Inc. | 2003 | — |
| −4 | K100434 | Clave Neutron | Icu Medical, Inc. | 2010 | 3 |
| −3 | K132413 | MZ1000 | Care Fusion | 2013 | — |
| −2 | 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 |
| 0 (this device) | K232234 | Nouvo Safety Set | Poly Medicure Limited | 2024 | — |
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 |
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 |
|---|---|---|---|
| * | K183399 | BD Nexiva Closed IV Catheter SystemSummary page 5…5200) Regulatory Class: II Primary Product Code FOZ III. PREDICATE DEVICE 510(k) Number: K183399 Name of Device: BD Nexiva™ Closed IV Catheter System Common Name or Usual Name: Intrav… | 2019 |
| † | K220288 | NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 7 companies; a new generation was cleared every 3.5 years on median.
- 11 of the 22 ancestors have a recall of any class.
- 3 other devices also cite its predicate K183399.
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. 2024, 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 Nouvo Safety Set IV Catheter are indicated for insertion into a patient's vascular system to sample blood, Infusion of fluids such as solutions, parenteral nutrition and administration of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. The 18G-22G catheters may be used intravascularly with power injectors at a maximum pressure of 300 psi.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232234 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232234: Nouvo Safety Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232234
Report an extraction error
Are you the manufacturer?
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