510(k) · Cleared
Recalled · 2003Open Ended Ureteral Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Van-Tec, Inc. · GBM Catheter, Urethral
Cleared on Apr 6, 1983 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 4 times.
- Decided
- Apr 6, 1983
- Review
- 21 days
- Class
- Class II
- Product code
- GBM
- Recalls
- 4
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GBM? 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 GBM device
- #1 K241734 Wellead® Hydrophilic Intermittent Catheter…score 10.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|---|
| Mar 17, 2003 | Not classified | Z-0734-03 | Other | Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use |
| Mar 17, 2003 | Not classified | Z-0740-03 | Other | Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use |
| Mar 17, 2003 | Not classified | Z-0735-03 | Other | Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use |
| Mar 17, 2003 | Not classified | Z-0736-03 | Other | Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use |
No ancestor or descendant has a Class I recall.
How does its category compare?
All GBM devicesGBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GBM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GBM
230in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GBM
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GBM
311in 2025
MAUDE reports naming product code GBM, 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 | 2 | — | 0 | 5 |
| 2008 | 0 | — | 5 | 18 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 33 |
| 2011 | 2 | — | 1 | 46 |
| 2012 | 3 | 139 | 0 | 32 |
| 2013 | 0 | — | 0 | 41 |
| 2014 | 1 | — | 0 | 19 |
| 2015 | 5 | 76 | 0 | 21 |
| 2016 | 3 | 112 | 0 | 49 |
| 2017 | 2 | — | 0 | 59 |
| 2018 | 6 | 93 | 0 | 82 |
| 2019 | 7 | 121 | 0 | 148 |
| 2020 | 6 | 230 | 0 | 144 |
| 2021 | 0 | — | 0 | 102 |
| 2022 | 2 | — | 0 | 283 |
| 2023 | 0 | — | 1 (1) | 202 |
| 2024 | 0 | — | 0 | 468 |
| 2025 | 1 | — | 1 | 311 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K830840 · printed Nov 4, 2026
Cite this page
510(k) Report. “K830840: Open Ended Ureteral Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K830840
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026