510(k) · Cleared
ClearedAQ Hydrophilic Urological Catheters
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 Jun 11, 1996 after a 20-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jun 11, 1996
- Review
- 20 days
- Class
- Class II
- Product code
- EYB
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK962004 AQ Hydrophilic Urological CathetersCook Urological, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK171043 Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip…Coloplast Corp. · 2017
- Descendant · 2 generations on · 1 of its ownK182122 Ureteric CathetersColoplast Corp. · 2018
- Descendant · 3 generations on · 0 of its ownK192183 RocaTub Ureteral CatheterPromepal Sam · 2020
- Descendant · cites it directly · 0 of its ownK182695 Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral…Cook Incorporated · 2019
Most influential descendants
Showing 4 of 4 · See all- K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric CathetersColoplast Corp. · 2017 · cites it directly2descendants
- K182122Ureteric CathetersColoplast Corp. · 2018 · 2 generations on1descendant
- K192183RocaTub Ureteral CatheterPromepal Sam · 2020 · 3 generations on0descendants
- K182695Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral CatheterCook Incorporated · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962004 | AQ Hydrophilic Urological Catheters | Cook Urological, Inc. | 1996 | — |
| +1 | K171043 | Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric… | Coloplast Corp. | 2017 | — |
| +2 | K182122 | Ureteric Catheters | Coloplast Corp. | 2018 | — |
| +3 | K192183 | RocaTub Ureteral Catheter | Promepal Sam | 2020 | — |
| +1 | K182695 | Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter | Cook Incorporated | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | — | Ship-Coat™ Catheters Named without a submission number | |
| * | — | uncoated urological catheters Named without a submission number |
What descends from it? (4)
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, K171043 (Coloplast Corp., 2017) has gone furthest, with 2 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 | — |
What is it indicated for?
The AQ Hydrophilic Urological Catheters are intended for drainage, irrigation and/or retrograde pyelogram.
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/K962004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962004: AQ Hydrophilic Urological Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962004
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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