510(k) · Cleared
ClearedCone Tip Ureteral Catheter, Rutner Universal Wedge Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · KOD Catheter, Urological
Cleared on Mar 7, 2018 as substantially equivalent to K760858 (Cook, Inc., 1976) and 1 other predicate after a 261-day review. Its family tree reaches back 1 generation to 1976.
- Decided
- Mar 7, 2018
- Review
- 261 days
- Class
- Class II
- Product code
- KOD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K760858 (1976). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK760858 Rutner Universal Wedge CatheterCook, Inc. · 1976
- This deviceK171810 Cone Tip Ureteral Catheter, Rutner Universal Wedge CatheterCook Incorporated · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K760858 | Rutner Universal Wedge Catheter | Cook, Inc. | 1976 | — |
| 0 (this device) | K171810 | Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter | Cook Incorporated | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 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? (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 |
|---|---|---|---|
| * | K760858 | Rutner Universal Wedge CatheterSummary page 5…21 CFR §876.5130 Product Code: KOD Predicate Devices: Cone Tip Ureteral Catheter • Rutner Universal Wedge Catheter - Cook Incorporated, K760858 • Van-Tec Open Ended Cone Tip Ureteral Catheter (Boston Scientific Cone Tip Ureteral Catheter), K870694* Rutner Uni… | 1976 |
| * | K870694 | Van-Tec Open Ended Cone Tip Ureteral CatheterSummary page 5…Rutner Universal Wedge Catheter - Cook Incorporated, K760858 • Van-Tec Open Ended Cone Tip Ureteral Catheter (Boston Scientific Cone Tip Ureteral Catheter), K870694* Rutner Universal Wedge Catheter • Rutner Universal Wedge Catheter - Cook Incorporated, K760858… | 1987 |
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.
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 Cone Tip Ureteral Catheter is intended for retrograde pyelogram.
The Rutner Universal Wedge Catheter is intended for retrograde pyelogram. The 4.0 Fr Rutner Universal Wedge Catheter is indicated for pediatric population 2 years and older.
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/K171810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171810: Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171810
Report an extraction error
Are you the manufacturer?
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