510(k) · Cleared
ClearedMulticath Expert
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 Sep 29, 2006 as substantially equivalent to K870067 (Vygon Corp., 1987) and 2 other predicates after a 148-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.
- Decided
- Sep 29, 2006
- Review
- 148 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K870067 (1987). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K072702Stryker Antimic CatheterStryker Instruments, Instruments Div. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K870067 | Multicath - Code#S 8.1207.OO/8.1208.00/8.1205.20 | Vygon Corp. | 1987 | — |
| 0 (this device) | K061250 | Multicath Expert | Vygon Corp. | 2006 | — |
| +1 | K072702 | Stryker Antimic Catheter | Stryker Instruments, Instruments Div. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (3)
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 |
|---|---|---|---|
| * | K870067 | Multicath - Code#S 8.1207.OO/8.1208.00/8.1205.20Summary page 1…Product Code: FOZ Classification Name: Intravascular Catheter Classification: Class II Predicate Device Name: Multicath (K870067), Vantex (K992532 / K033250) Device Description: The Multicath Expert catheters are a line of multilumen catheters… | 1987 |
| * | K992532 | Vantex Central Venous Catheter with Oligon Material with or Without Amc Thromboshield…Summary page 1…FOZ Classification Name: Intravascular Catheter Classification: Class II Predicate Device Name: Multicath (K870067), Vantex (K992532 / K033250) Device Description: The Multicath Expert catheters are a line of multilumen catheters which have an anti… | 2000 |
| * | K033250 | Edwards Lifesciences Vantex Central Venous Catheters with ThermistorSummary page 1…FOZ Classification Name: Intravascular Catheter Classification: Class II Predicate Device Name: Multicath (K870067), Vantex (K992532 / K033250) Device Description: The Multicath Expert catheters are a line of multilumen catheters which have an antimicrobial… | 2003 |
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 |
|---|---|---|---|
| K072702 | Stryker Antimic Catheter | 2008 | 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?
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K072702 (Stryker Instruments, Instruments Div., 2008) 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.
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 Vygon Multicath Expert Catheter is intended for use in patients who require
Short-term (less than 30 days) I.V. therapy. It may be used to administer
hyperalimentation, antibiotics, chemotherapy, drugs for pain management or
intravenous fluids. The catheters are manufactured with a Pellethane-based AgIONTM
antimicrobial. The AglON T" uses silver as the antimicrobial agent.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061250 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061250: Multicath Expert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061250
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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