510(k) · Cleared
ClearedUreteral Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Urological, Inc. · EYB Catheter, Ureteral, Gastro-Urology
Cleared on Dec 7, 1993 after a 498-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Dec 7, 1993
- Review
- 498 days
- Class
- Class II
- Product code
- EYB
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK923729 Ureteral CatheterCook Urological, Inc. · 1993
- Descendant · cites it directly · 1 of its ownK020577 Applied Ureteral CatheterApplied Medical Resources Corp. · 2002
- Descendant · 2 generations on · 0 of its ownK061661 Sta Cath Attachable Infision Catheter, Model STA20Advanced Infusion, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK964899 Kendall Curity Ureteral CatheterKendall Healthcare Products Co. Div.Of Tyco Health · 1997
Most influential descendants
Showing 3 of 3 · See all- K020577Applied Ureteral CatheterApplied Medical Resources Corp. · 2002 · cites it directly1descendant
- K061661Sta Cath Attachable Infision Catheter, Model STA20Advanced Infusion, Inc. · 2006 · 2 generations on0descendants
- K964899Kendall Curity Ureteral CatheterKendall Healthcare Products Co. Div.Of Tyco Health · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K923729 | Ureteral Catheter | Cook Urological, Inc. | 1993 | — |
| +1 | K020577 | Applied Ureteral Catheter | Applied Medical Resources Corp. | 2002 | — |
| +2 | K061661 | Sta Cath Attachable Infision Catheter, Model STA20 | Advanced Infusion, Inc. | 2006 | — |
| +1 | K964899 | Kendall Curity Ureteral Catheter | Kendall Healthcare Products Co. Div.Of Tyco Health | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
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?
- Of its descendants, K020577 (Applied Medical Resources Corp., 2002) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EYB devicesEYB Catheter, Ureteral, Gastro-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K923729 · printed Nov 6, 2026
Cite this page
510(k) Report. “K923729: 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/K923729
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026