510(k) · Cleared
ClearedRenal Access Cobra Catheter, Kumpe Access 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 16, 2018 as substantially equivalent to K102527 (Boston Scientific Corporation, 2010) after a 260-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.
- Decided
- Feb 16, 2018
- Review
- 260 days
- Class
- Class II
- Product code
- KOD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K965229 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK965229 Imager Torque CatheterBoston Scientific Corp · 1997
- 2 generations backK011965 Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1Boston Scientific Corp · 2001 · Recalled
- 1 generation backK102527 Imager II Urology Torque Catheter (C1 Tip); Imager II Urology Torque…Boston Scientific Corporation · 2010 · Recalled
- This deviceK171600 Renal Access Cobra Catheter, Kumpe Access CatheterCook Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK181144 Angled Tip Ureteral CatheterCook Incorporated · 2018
Most influential descendants
Showing 1 of 1 · See all- K181144Angled Tip Ureteral CatheterCook Incorporated · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K965229 | Imager Torque Catheter | Boston Scientific Corp | 1997 | — |
| −2 | K011965 | Imager II Urology Torque Catheter, Model 40030X1, 40040X1, and 40050X1 | Boston Scientific Corp | 2001 | 2 |
| −1 | K102527 | Imager II Urology Torque Catheter (C1 Tip); Imager II Urology Torque Catheter… | Boston Scientific Corporation | 2010 | 1 |
| 0 (this device) | K171600 | Renal Access Cobra Catheter, Kumpe Access Catheter | Cook Incorporated | 2018 | — |
| +1 | K181144 | Angled Tip Ureteral Catheter | Cook Incorporated | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K102527 | Imager II Urology Torque Catheter (C1 Tip); Imager II Urology Torque Catheter (C2 Tip…Summary page 5…Regulation: 21 CFR §876.5130, Product Code KOD Device Class/Classification Panel: Class II, Gastroenterology/Urology Predicate Device: Imager™ II Catheter (K102527) Subject Device Descriptions: The Renal Access Cobra Catheter is used in the delivery of contrast media as well as access, adva… | 2010 |
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 |
|---|---|---|---|
| K181144 | Angled Tip Ureteral Catheter | 2018 | 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 7.3 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K181144 (Cook Incorporated, 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K102527.
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?
This device is intended for delivery of contrast media as well as access, advancement, or exchange of wire guides in the renal area.
These devices are intended for access and catheterization of the urinary tract, including the following applications:
Delivery of contrast media
Navigation of a tortuous ureter
Access, advancement, or exchange of wire guides
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171600 · printed Nov 4, 2026
Cite this page
510(k) Report. “K171600: Renal Access Cobra Catheter, Kumpe Access Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K171600
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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