510(k) · Cleared
ClearedUreteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast Corp. · EYB Catheter, Ureteral, Gastro-Urology
Cleared on Dec 21, 2017 as substantially equivalent to K962004 (Cook Urological, Inc., 1996) after a 258-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Dec 21, 2017
- Review
- 258 days
- Class
- Class II
- Product code
- EYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962004 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK962004 AQ Hydrophilic Urological CathetersCook Urological, Inc. · 1996
- This deviceK171043 Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip…Coloplast Corp. · 2017
- Descendant · cites it directly · 1 of its ownK182122 Ureteric CathetersColoplast Corp. · 2018
- Descendant · 2 generations on · 0 of its ownK192183 RocaTub Ureteral CatheterPromepal Sam · 2020
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 |
|---|---|---|---|---|---|
| −1 | K962004 | AQ Hydrophilic Urological Catheters | Cook Urological, Inc. | 1996 | — |
| 0 (this device) | K171043 | Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric… | Coloplast Corp. | 2017 | — |
| +1 | K182122 | Ureteric Catheters | Coloplast Corp. | 2018 | — |
| +2 | K192183 | RocaTub Ureteral Catheter | Promepal Sam | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 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 EYB? 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 EYB device
- #1 K192183 RocaTub Ureteral Catheterscore -0.2 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K962004 | AQ Hydrophilic Urological CathetersSummary page 4…Regulatory Class: II Product Code: EYB III. Predicate Device Trade Name: Pigtail Ureteral Catheter set (K962004) Common / Usual Name: Catheter, Ureteral, Gastro-Urology Classification Name: Urological catheter… | 1996 |
| † | K021856 | Porges Ureteral Catheters, Models ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182122 | Ureteric Catheters | 2018 | 1 |
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?
How does its category compare?
All EYB devicesEYB Catheter, Ureteral, Gastro-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · EYB
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · EYB
248in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EYB
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EYB
11in 2025
MAUDE reports naming product code EYB, 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 | 14 |
| 2008 | 0 | — | 1 | 15 |
| 2009 | 1 | — | 0 | 42 |
| 2010 | 1 | — | 0 | 13 |
| 2011 | 0 | — | 0 | 11 |
| 2012 | 0 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 14 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 10 |
| 2018 | 2 | — | 0 | 8 |
| 2019 | 3 | 248 | 0 | 22 |
| 2020 | 1 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 1 | 5 |
| 2023 | 0 | — | 0 | 23 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
Ureteric catheters are intended for endourological procedures, to restore or maintain drainage of the upper urinary tract and to inject contrast medium or saline.
Duration of use: Ureteric catheters are intended for temporary use during surgical procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171043: Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171043
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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