510(k) · Cleared
ClearedBard Flexible Tip Ureteral Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · EYB Catheter, Ureteral, Gastro-Urology
Cleared on Apr 27, 1995 after a 92-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Apr 27, 1995
- Review
- 92 days
- Class
- Class II
- Product code
- EYB
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK950300 Bard Flexible Tip Ureteral CatheterC.R. Bard, Inc. · 1995
- Descendant · cites it directly · 5 of its ownK021856 Porges Ureteral Catheters, Models ACN6XX, ACN5XX, AC5B, AC5C07…Porges S.A. · 2002
- Descendant · 2 generations on · 2 of its ownK171662 Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex…Cook Incorporated · 2018
- Descendant · 2 generations on · 1 of its ownK182122 Ureteric CathetersColoplast Corp. · 2018
- Descendant · 3 generations on · 0 of its ownK220036 Wellead Ureteral CatheterWell Lead Medical Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK192183 RocaTub Ureteral CatheterPromepal Sam · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K021856Porges Ureteral Catheters, Models ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX…Porges S.A. · 2002 · cites it directly5descendants
- K171662Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End…Cook Incorporated · 2018 · 2 generations on2descendants
- K182122Ureteric CathetersColoplast Corp. · 2018 · 2 generations on1descendant
- K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd. · 2022 · 3 generations on0descendants
- K192183RocaTub Ureteral CatheterPromepal Sam · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K171662 | Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip… | Cook Incorporated | 2018 | — |
| +2 | K182122 | Ureteric Catheters | Coloplast Corp. | 2018 | — |
| +3 | K220036 | Wellead Ureteral Catheter | Well Lead Medical Co., Ltd. | 2022 | — |
| +3 | K192183 | RocaTub Ureteral Catheter | Promepal Sam | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (7)
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, K021856 (Porges S.A., 2002) has gone furthest, with 5 descendants 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/K950300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950300: Bard Flexible Tip 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/K950300
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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