510(k) · Cleared
ClearedOpen-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral 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 Feb 1, 2018 as substantially equivalent to K033719 (C.R. Bard, Inc., 2004) and 1 other predicate after a 241-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- Feb 1, 2018
- Review
- 241 days
- Class
- Class II
- Product code
- KOD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K950300 (1995). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK950300 Bard Flexible Tip Ureteral CatheterC.R. Bard, Inc. · 1995
- 1 generation backK021856 Porges Ureteral Catheters, Models ACN6XX, ACN5XX, AC5B, AC5C07…Porges S.A. · 2002
- This deviceK171662 Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex…Cook Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK220036 Wellead Ureteral CatheterWell Lead Medical Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK191187 Dornier MINNOW Ureteral CatheterDornier Medtech America, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950300 | Bard Flexible Tip Ureteral Catheter | C.R. Bard, Inc. | 1995 | — |
| −1 | K021856 | Porges Ureteral Catheters, Models ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX… | Porges S.A. | 2002 | — |
| 0 (this device) | K171662 | Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip… | Cook Incorporated | 2018 | — |
| +1 | K220036 | Wellead Ureteral Catheter | Well Lead Medical Co., Ltd. | 2022 | — |
| +1 | K191187 | Dornier MINNOW Ureteral Catheter | Dornier Medtech America, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K033719 | Bard Tigertail Ureteral CatheterSummary page 4…5130, Class II Product Code, Panel: KOD, Gastroenterology/Urology Predicate Devices: • Primary predicate device: Bard TigerTail Ureteral Catheter (K033719) • Secondary predicate device: Porges Ureteral Catheters (K021856) Device Description: The Ureteral Catheter family is com… | 2004 |
| * | K021856 | Porges Ureteral Catheters, Models ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX…Summary page 4…gy/Urology Predicate Devices: • Primary predicate device: Bard TigerTail Ureteral Catheter (K033719) • Secondary predicate device: Porges Ureteral Catheters (K021856) Device Description: The Ureteral Catheter family is comprised of nine different types of Ureteral Catheters. The types of cath… | 2002 |
| † | K760858 | Rutner Universal Wedge Catheter | 1976 |
| † | K162104 | C-Flex Ureteral Stent Set | 2017 |
What descends from it? (2)
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)
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 23 years and passes through 3 companies; a new generation was cleared every 15.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K220036 (Well Lead Medical Co., Ltd., 2022) 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?
Ureteral catheters are indicated for access and catheterization of the urinary tract, including the following applications:
• Delivery of contrast media
• Drainage of fluids from the urinary tract
• Delivery of irrigation fluids to the urinary tract
• Navigation of a tortuous ureter
• Access, advancement, or exchange of wire guides (open-ended catheters only)
The Pediatric Ureteral Catheter is indicated for access and catheterization of the urinary tract in pediatric patients, including the following applications:
• Delivery of contrast media
• Drainage of fluids from the urinary tract
• Delivery of irrigation fluids to the urinary tract
• Navigation of a tortuous ureter
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171662 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171662: Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171662
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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