510(k) · Cleared
ClearedUroGen Ureteral Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Urogen Pharma, Ltd. · KOD Catheter, Urological
Cleared on Oct 30, 2018 as substantially equivalent to K110491 (Pluromed, Inc., 2011) after a 264-day review. Its family tree reaches back 5 generations to 1997. 1 later device descends from it.
- Decided
- Oct 30, 2018
- Review
- 264 days
- Class
- Class II
- Product code
- KOD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K965229 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK965229 Imager Torque CatheterBoston Scientific Corp · 1997
- 4 generations backK011965 Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1Boston Scientific Corp · 2001 · Recalled
- 3 generations backK090270 Backstop Catheter, Model 60-0000-3100Pluromed, Inc. · 2009
- 2 generations backK103349 Backstop CatheterPluromed, Inc. · 2011
- 1 generation backK110491 Backstop CatheterPluromed, Inc. · 2011
- This deviceK180354 UroGen Ureteral CatheterUrogen Pharma, Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK211032 Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K965229 | Imager Torque Catheter | Boston Scientific Corp | 1997 | — |
| −4 | K011965 | Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1 | Boston Scientific Corp | 2001 | 2 |
| −3 | K090270 | Backstop Catheter, Model 60-0000-3100 | Pluromed, Inc. | 2009 | — |
| −2 | K103349 | Backstop Catheter | Pluromed, Inc. | 2011 | — |
| −1 | K110491 | Backstop Catheter | Pluromed, Inc. | 2011 | — |
| 0 (this device) | K180354 | UroGen Ureteral Catheter | Urogen Pharma, Ltd. | 2018 | — |
| +1 | K211032 | Urinary Catheter 12 Fr, Urinary Catheter 16 Fr | Urogen Pharma, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 KOD? 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 KOD device
- #1 K251864 Rubber Utility Catheterscore 10.9 · 1 generation · 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 |
|---|---|---|---|
| * | K110491 | Backstop CatheterSummary page 4…ation Panel: Gastroenterology-Urology 3. PREDICATE DEVICES Primary predicate: • Backstop Catheter, by Pluromed, Inc., product code KOD; cleared under K110491 Reference devices: • Ureteral Catheter, by Boston Scientific, product code: GBM; cleared under K830840… | 2011 |
| † | K830840 | Open Ended Ureteral Catheter | 1983 |
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 |
|---|---|---|---|
| K211032 | Urinary Catheter 12 Fr, Urinary Catheter 16 Fr | 2021 | 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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K211032 (Urogen Pharma, Ltd., 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KOD devicesKOD Catheter, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KOD
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · KOD
251in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KOD
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KOD
1,389in 2025
MAUDE reports naming product code KOD, 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 | 0 | — | 0 | 180 |
| 2008 | 2 | — | 0 | 102 |
| 2009 | 1 | — | 15 | 183 |
| 2010 | 1 | — | 1 | 228 |
| 2011 | 2 | — | 47 | 209 |
| 2012 | 0 | — | 2 | 165 |
| 2013 | 0 | — | 0 | 393 |
| 2014 | 1 | — | 0 | 226 |
| 2015 | 0 | — | 0 | 418 |
| 2016 | 2 | — | 1 | 284 |
| 2017 | 1 | — | 0 | 1,873 |
| 2018 | 6 | 251 | 0 | 1,179 |
| 2019 | 1 | — | 1 | 1,167 |
| 2020 | 0 | — | 0 | 1,370 |
| 2021 | 1 | — | 0 | 1,388 |
| 2022 | 2 | — | 3 | 1,280 |
| 2023 | 0 | — | 1 (1) | 1,160 |
| 2024 | 0 | — | 0 | 1,259 |
| 2025 | 0 | — | 0 | 1,389 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The UroGen Ureteral Catheter is indicated for use by physicians for facilitating access to the urinary tract through a retrograde route and may be used in conjunction with a guidewire or for the injection of gels or fluids into the urinary tract.
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/K180354 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180354: UroGen Ureteral Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180354
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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