510(k) · Cleared
ClearedVantagecath Intravascular Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advantage Medical Device · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Apr 30, 2008 as substantially equivalent to K032843 (Becton Dickinson Infusion Therapy Systems, Inc., 2004) and 1 other predicate after a 141-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Apr 30, 2008
- Review
- 141 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K971339 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK971339 Insyte, Insyte-W, Insyte Autoguard CathetersBecton Dickinson Vascular Access, Inc. · 1997
- This deviceK073471 Vantagecath Intravascular CatheterAdvantage Medical Device · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971339 | Insyte, Insyte-W, Insyte Autoguard Catheters | Becton Dickinson Vascular Access, Inc. | 1997 | — |
| 0 (this device) | K073471 | Vantagecath Intravascular Catheter | Advantage Medical Device | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K032843 | Nexiva Closed IV Catheter SystemSummary page 1…00 Predicate Device: BD Nexiva' M Closed IV Catheter System BD InsyteTm Autoguard Intravascular Catheter Predicate 510(k) #:K032843 (BD Nexiva)/K97 1339 (BD Insyte Autoguard) Device Description: The VantageCath'" is a short-term intr… | 2004 |
| * | K971339 | Insyte, Insyte-W, Insyte Autoguard CathetersSummary page 1…D Nexiva' M Closed IV Catheter System BD InsyteTm Autoguard Intravascular Catheter Predicate 510(k) #:K032843 (BD Nexiva)/K97 1339 (BD Insyte Autoguard) Device Description: The VantageCath'" is a short-term intravascular catheter… | 1997 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 7 other devices also cite its predicate K032843.
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. 2008, 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 VantageCath TM is a short-term intravascular catheter which allows health care practitioner to sample blood and administer fluids or medication intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused, and the duration of therapy.
The VantageCath TM catheter provides a shielding mechanism intended to reduce the incidence of accidental needle sticks. When the needle retracts into the needle-shielding barrel, the catheter hub and needle assembly components are automatically separated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073471 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073471: Vantagecath Intravascular Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073471
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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