510(k) · Cleared
ClearedUreteric 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 Oct 4, 2018 as substantially equivalent to K021856 (Porges S.A., 2002) and 1 other predicate after a 59-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Oct 4, 2018
- Review
- 59 days
- Class
- Class II
- Product code
- EYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K950300 (1995). 4 ancestors in all. 1 later device descends from it, 1 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 deviceK182122 Ureteric CathetersColoplast Corp. · 2018
- Descendant · cites it directly · 0 of its ownK192183 RocaTub Ureteral CatheterPromepal Sam · 2020
Most influential descendants
Showing 1 of 1 · See all- K192183RocaTub Ureteral CatheterPromepal Sam · 2020 · cites it directly0descendants
View 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) | K182122 | Ureteric Catheters | Coloplast Corp. | 2018 | — |
| +1 | K192183 | RocaTub Ureteral Catheter | Promepal Sam | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K021856 | Porges Ureteral Catheters, Models ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX…Summary page 4…rs are substantially equivalent in performance, indication, and design to the primary predicate, PORGESTM Ureteral Catheters, cleared under premarket notification number K021856. In addition to the primary predicate, the Floppy Tip Hydro-Coated Ureteric Catheter, cleared under premarket notification numbe… | 2002 |
| * | K171043 | Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric CathetersSummary page 4…premarket notification number K021856. In addition to the primary predicate, the Floppy Tip Hydro-Coated Ureteric Catheter, cleared under premarket notification number K171043, is a secondary predicate for this submission. The Floppy Tip Hydro-Coated Ureteric Catheters are made from similar materials as… | 2017 |
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 |
|---|---|---|---|
| K192183 | RocaTub Ureteral Catheter | 2020 | 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 23 years and passes through 3 companies; a new generation was cleared every 16.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K192183 (Promepal Sam, 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K021856.
How does its category compare?
All EYB devicesEYB Catheter, Ureteral, Gastro-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 for retrograde ureteropyelography are intended for injection of contrast medium or saline during endourological procedures.
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/K182122 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182122: 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/K182122
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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