510(k) · Cleared
Recalled · Class II · 2015Modification to: Latex-Free Bionector, Model# 896.019, 896.039
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vygon Corp. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Nov 30, 2007 as substantially equivalent to K052881 (Vygon Corp., 2006) after a 261-day review. Its family tree reaches back 2 generations to 1995. It has been recalled 13 times.
- Decided
- Nov 30, 2007
- Review
- 261 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 13
- Predicates
- 1
Its longest line of descent runs back 2 generations to K941678 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K052881 | Vygon Latex Free Bionector | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 15, 2015 | Class II | Z-1472-2015 | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. |
| Jan 15, 2015 | Class II | Z-1474-2015 | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. |
| Jan 15, 2015 | Class II | Z-1470-2015 | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. |
| Jan 15, 2015 | Class II | Z-1475-2015 | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. |
| Jan 15, 2015 | Class II | Z-1473-2015 | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. |
| Jan 15, 2015 | Class II | Z-1467-2015 | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. |
| Jan 15, 2015 | Class II | Z-1477-2015 | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. |
| Jan 15, 2015 | Class II | Z-1468-2015 | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. |
| Jan 15, 2015 | Class II | Z-1478-2015 | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. |
| Jan 15, 2015 | Class II | Z-1471-2015 | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. |
| Jan 15, 2015 | Class II | Z-1476-2015 | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. |
| Jan 15, 2015 | Class II | Z-1469-2015 | Process design | Potential for leaking caused by insufficient bond between needleless device and female luer. |
| Aug 28, 2014 | Class II | Z-0113-2015 | Component design/selection | Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleless connector. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 10.7 years on median.
- None of the 2 ancestors has a recall.
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. 2007, 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?
LATEX-FREE BIONECTOR is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermittent injection or continuous infusion of fluids or medications. Connection is exclusively with the Male/Female Luer system which does not displace fluid upon either connection or disconnection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070705 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070705: Modification to: Latex-Free Bionector, Model# 896.019, 896.039.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070705
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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