510(k) · Cleared
ClearedPorges Ureteral Catheters, Models ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Porges S.A. · EYB Catheter, Ureteral, Gastro-Urology
Cleared on Oct 17, 2002 as substantially equivalent to K950300 (C.R. Bard, Inc., 1995) after a 133-day review. Its family tree reaches back 1 generation to 1995. 5 later devices descend from it.
- Decided
- Oct 17, 2002
- Review
- 133 days
- Class
- Class II
- Product code
- EYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950300 (1995). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK950300 Bard Flexible Tip Ureteral CatheterC.R. Bard, Inc. · 1995
- This deviceK021856 Porges Ureteral Catheters, Models ACN6XX, ACN5XX, AC5B, AC5C07…Porges S.A. · 2002
- Descendant · cites it directly · 2 of its ownK171662 Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex…Cook Incorporated · 2018
- Descendant · cites it directly · 1 of its ownK182122 Ureteric CathetersColoplast Corp. · 2018
- Descendant · 2 generations on · 0 of its ownK220036 Wellead Ureteral CatheterWell Lead Medical Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK192183 RocaTub Ureteral CatheterPromepal Sam · 2020
- Descendant · 2 generations on · 0 of its ownK191187 Dornier MINNOW Ureteral CatheterDornier Medtech America, Inc. · 2019
Most influential descendants
Showing 5 of 5 · See all- K171662Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End…Cook Incorporated · 2018 · cites it directly2descendants
- K182122Ureteric CathetersColoplast Corp. · 2018 · cites it directly1descendant
- K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd. · 2022 · 2 generations on0descendants
- K192183RocaTub Ureteral CatheterPromepal Sam · 2020 · 2 generations on0descendants
- K191187Dornier MINNOW Ureteral CatheterDornier Medtech America, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950300 | Bard Flexible Tip Ureteral Catheter | C.R. Bard, Inc. | 1995 | — |
| 0 (this device) | K021856 | Porges Ureteral Catheters, Models ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX… | Porges S.A. | 2002 | — |
| +1 | K171662 | Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip… | Cook Incorporated | 2018 | — |
| +1 | K182122 | Ureteric Catheters | Coloplast Corp. | 2018 | — |
| +2 | K220036 | Wellead Ureteral Catheter | Well Lead Medical Co., Ltd. | 2022 | — |
| +2 | K192183 | RocaTub Ureteral Catheter | Promepal Sam | 2020 | — |
| +2 | K191187 | Dornier MINNOW Ureteral Catheter | Dornier Medtech America, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K950300 | Bard Flexible Tip Ureteral CatheterSummary page 1…RGESTMpre-amendment range of ureteral catheters, C.R. Bard Inc. Urological Division's currently marketed ureteral catheter line and Bard@ Flexible Tip Ureteral catheter (K950300). PORGES S.A.. is not aware of any information suggesting that C.R. Bard Inc. ureteral catheters are not legally marketed. Ureter… | 1995 |
| * | — | PORGES pre-amendment range of ureteral catheters Named without a submission number | |
| * | — | C.R. Bard Inc. currently marketed ureteral catheter line Named without a submission number |
What descends from it? (5)
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?
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 | — |
What is it indicated for?
The PORGES Ureteral catheters are used for ureteral catheterisation:
- drainage catheters: straight catheters with bevel, olive or cylindrical tip, elbowed catheter with olive tip
- catheters for retrograde ureteropyelography (R.U.P.):Chevassu, cone or Braasch
- interventional catheters: flush, open straight, open elbowed. The appropriate guide-wire size for each catheter is shown on the box.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021856 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021856: Porges Ureteral Catheters, Models ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021856
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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