510(k) · Cleared
Recalled · 2006Vantex Central Venous Catheter with Oligon Material with or Without Amc Thromboshield Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Jun 13, 2000 after a 320-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 13, 2000
- Review
- 320 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 2
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK992532 Vantex Central Venous Catheter with Oligon Material with or Without…Baxter Healthcare Corp · 2000
- Descendant · cites it directly · 1 of its ownK061250 Multicath ExpertVygon Corp. · 2006
- Descendant · cites it directly · 0 of its ownK113565 Multi-Med Central Venous Catheters (CVCS), with and Without Heparin…Edwards Lifesciences, LLC · 2012
- Descendant · 2 generations on · 0 of its ownK072702 Stryker Antimic CatheterStryker Instruments, Instruments Div. · 2008
Most influential descendants
Showing 3 of 3 · See all- K061250Multicath ExpertVygon Corp. · 2006 · cites it directly1descendant
- K113565Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex Central…Edwards Lifesciences, LLC · 2012 · cites it directly0descendants
- K072702Stryker Antimic CatheterStryker Instruments, Instruments Div. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992532 | Vantex Central Venous Catheter with Oligon Material with or Without Amc… | Baxter Healthcare Corp | 2000 | — |
| +1 | K061250 | Multicath Expert | Vygon Corp. | 2006 | — |
| +1 | K113565 | Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex… | Edwards Lifesciences, LLC | 2012 | — |
| +2 | K072702 | Stryker Antimic Catheter | Stryker Instruments, Instruments Div. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 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? (2)
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 |
|---|---|---|---|
| * | — | Multi-Med Multi-Lumen Central Venous Catheter with AMC™ Thromboshield™ Named without a submission number | |
| * | — | Arrow International’s Central Venous Multi-Lumen Catheter with ARROWgard Blue Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 2, 2006 | Not classified | Z-0318-2007 | Other | Lack of Assurance of Sterility-Device packaging was manufactured with an incorrect lid that could compromise the sterility of the product. |
| Oct 8, 2003 | Not classified | Z-0272-04 | Other | Lot is being recalled because some of the kits contain an incorrect guidewire. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061250 (Vygon Corp., 2006) has gone furthest, with 1 descendant 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 Vantex™ Central Venous Catheter with OLIGON™ with or without AMC™ Thromboshield™ coating are indicated for use in patients requiring ptessure monitoring, infusion of solutions, and blood sampling in the central vein. All catheters are manufactured with a polyurcthane-based OLIGON™ antimicrobial polymer. The OLIGON™ material uses silver as the antimicrobial agent.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992532 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992532: Vantex Central Venous Catheter with Oligon Material with or Without Amc Thromboshield Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992532
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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