510(k) · Decided
DecidedPigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · EYB Catheter, Ureteral, Gastro-Urology
Cleared on Jun 17, 2019 as substantially equivalent to K962004 (Cook Urological, Inc., 1996) after a 263-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jun 17, 2019
- Review
- 263 days
- Class
- Class II
- Product code
- EYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962004 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK962004 AQ Hydrophilic Urological CathetersCook Urological, Inc. · 1996
- This deviceK182695 Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral…Cook Incorporated · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962004 | AQ Hydrophilic Urological Catheters | Cook Urological, Inc. | 1996 | — |
| 0 (this device) | K182695 | Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter | Cook Incorporated | 2019 | — |
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? (1)
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 |
|---|---|---|---|
| * | K962004 | AQ Hydrophilic Urological CathetersSummary page 4…stroenterology/Urology Predicate Device: The predicate device is the AQ® Hydrophilic Urological Catheter manufactured by Cook Urological, Inc, which was cleared under K962004. Predicate Device: AQ® Hydrophilic Urological Catheter (K962004) Reference Device: Open-End Ureteral Catheter Sof-Flex… | 1996 |
| † | K171662 | Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K962004.
How does its category compare?
All EYB devicesEYB Catheter, Ureteral, Gastro-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Indicated for drainage or irrigation in the urinary tract as well as access, advancement or exchange of wire guides.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182695 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182695: Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail 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/K182695
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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