510(k) · Cleared
Recalled · Class II · 2019AQ Hydrophilic Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Urological, Inc. · FAD Stent, Ureteral
Cleared on May 28, 1996 as substantially equivalent to K905289 (Medical Engineering Corp., 1991) after a 42-day review. Its family tree reaches back 1 generation to 1991. 14 later devices descend from it. It has been recalled 18 times.
- Decided
- May 28, 1996
- Review
- 42 days
- Class
- Class II
- Product code
- FAD
- Recalls
- 18
- Predicates
- 1
Its longest line of descent runs back 1 generation to K905289 (1991). 14 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK905289 Surgitek (R) Lubri-Flex (TM) Ureteral StentMedical Engineering Corp. · 1991
- This deviceK961446 AQ Hydrophilic StentCook Urological, Inc. · 1996
- Descendant · cites it directly · 11 of its ownK151051 Universa Soft Ureteral Stents and Stent SetsCook Incorporated · 2016 · Recalled
- Descendant · 2 generations on · 5 of its ownK161236 Universa Firm Ureteral Stents and Stent SetsCook Incorporated · 2017 · Recalled
- Descendant · 3 generations on · 2 of its ownK213444 RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF…Ureteral Stent Company · 2022
- Descendant · 2 generations on · 1 of its ownK173734 RocaJJ Soft StentsPromepla Sam · 2018
- Descendant · 2 generations on · 1 of its ownK162104 C-Flex Ureteral Stent SetCook Incorporated · 2017
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K151051Universa Soft Ureteral Stents and Stent SetsCook Incorporated · 2016 · cites it directly11descendants
- K161236Universa Firm Ureteral Stents and Stent SetsCook Incorporated · 2017 · 2 generations on5descendants
- K213444RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit…Ureteral Stent Company · 2022 · 3 generations on2descendants
- K173734RocaJJ Soft StentsPromepla Sam · 2018 · 2 generations on1descendant
- K162104C-Flex Ureteral Stent SetCook Incorporated · 2017 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905289 | Surgitek (R) Lubri-Flex (TM) Ureteral Stent | Medical Engineering Corp. | 1991 | — |
| 0 (this device) | K961446 | AQ Hydrophilic Stent | Cook Urological, Inc. | 1996 | — |
| +1 | K151051 | Universa Soft Ureteral Stents and Stent Sets | Cook Incorporated | 2016 | 2 |
| +2 | K161236 | Universa Firm Ureteral Stents and Stent Sets | Cook Incorporated | 2017 | 1 |
| +3 | K213444 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent… | Ureteral Stent Company | 2022 | — |
| +2 | K173734 | RocaJJ Soft Stents | Promepla Sam | 2018 | — |
| +2 | K162104 | C-Flex Ureteral Stent Set | Cook Incorporated | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 FAD? 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 FAD device
- #1 K251890 Disposable Ureteral Stentsscore 12.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K905289 | Surgitek (R) Lubri-Flex (TM) Ureteral StentSummary page 1…truction. Predicate devices include the Slipcoat™ Stent manufactured by Cook Urological, the Hydro-Plus™ manufactured by Microvasive and the Lubri-Flex™ Ureteral Stent, K905289, manufactured by Surgilek®. Device Description: The AQ Hydrophilic Stent is used for temporary internal drainage from the urete… | 1991 |
| * | — | Slipcoat™ Stent Named without a submission number | |
| * | — | Hydro-Plus™ Named without a submission number |
What descends from it? (14)
See all 143 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 4, 2019 | Class II | Z-0977-2020 | Process control | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. |
| Oct 18, 2010 | Not classified | Z-0852-2011 | Packaging | The firm received a customer complaint that a box labeled as Universa Firm Stents but the box actually contained Universa Soft Stents. The inner product label is correct but the outer box is wrong. |
| Nov 10, 2008 | Not classified | Z-0980-2009 | Labeling mix-ups | "Soft" stents were placed in "firm" stent outer boxes. The soft stent is only to be left in the patient for 6 months, but the firm stent can be left in the patient for 12 months, so this error could result in the stent being left in the… |
| Jul 31, 2008 | Not classified | Z-0842-2009 | Process control | The bond may break where the two materials meet, resulting in separation of the stent. |
| Jul 31, 2008 | Not classified | Z-0845-2009 | Process control | The bond may break where the two materials meet, resulting in separation of the stent. |
| Jul 31, 2008 | Not classified | Z-0851-2009 | Process control | The bond may break where the two materials meet, resulting in separation of the stent. |
| Jul 31, 2008 | Not classified | Z-0844-2009 | Process control | The bond may break where the two materials meet, resulting in separation of the stent. |
| Jul 31, 2008 | Not classified | Z-0846-2009 | Process control | The bond may break where the two materials meet, resulting in separation of the stent. |
| Jul 31, 2008 | Not classified | Z-0848-2009 | Process control | The bond may break where the two materials meet, resulting in separation of the stent. |
| Jul 31, 2008 | Not classified | Z-0852-2009 | Process control | The bond may break where the two materials meet, resulting in separation of the stent. |
| Jul 31, 2008 | Not classified | Z-0853-2009 | Process control | The bond may break where the two materials meet, resulting in separation of the stent. |
| Jul 31, 2008 | Not classified | Z-0840-2009 | Process control | The bond may break where the two materials meet, resulting in separation of the stent. |
| Jul 31, 2008 | Not classified | Z-0841-2009 | Process control | The bond may break where the two materials meet, resulting in separation of the stent. |
| Jul 31, 2008 | Not classified | Z-0843-2009 | Process control | The bond may break where the two materials meet, resulting in separation of the stent. |
| Jul 31, 2008 | Not classified | Z-0847-2009 | Process control | The bond may break where the two materials meet, resulting in separation of the stent. |
| Jul 31, 2008 | Not classified | Z-0839-2009 | Process control | The bond may break where the two materials meet, resulting in separation of the stent. |
| Jul 31, 2008 | Not classified | Z-0849-2009 | Process control | The bond may break where the two materials meet, resulting in separation of the stent. |
| Jul 31, 2008 | Not classified | Z-0850-2009 | Process control | The bond may break where the two materials meet, resulting in separation of the stent. |
The 5 latest of 18 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FAD devicesFAD Stent, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FAD
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAD
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAD
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAD
634in 2025
MAUDE reports naming product code FAD, 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 | 1 | — | 1 | 43 |
| 2008 | 1 | — | 22 | 76 |
| 2009 | 0 | — | 2 | 123 |
| 2010 | 1 | — | 1 | 78 |
| 2011 | 0 | — | 0 | 95 |
| 2012 | 0 | — | 0 | 131 |
| 2013 | 0 | — | 0 | 82 |
| 2014 | 1 | — | 0 | 78 |
| 2015 | 0 | — | 0 | 130 |
| 2016 | 4 | 143 | 4 | 182 |
| 2017 | 8 | 266 | 0 | 265 |
| 2018 | 9 | 258 | 0 | 277 |
| 2019 | 5 | 263 | 6 | 261 |
| 2020 | 1 | — | 2 | 352 |
| 2021 | 2 | — | 1 | 531 |
| 2022 | 5 | 143 | 9 | 559 |
| 2023 | 0 | — | 0 | 691 |
| 2024 | 1 | — | 0 | 603 |
| 2025 | 4 | 186 | 4 | 634 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The AQ Hydrophilic Stent is used for temporary internal drainage from the ureteropelvic junction to the bladder.
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/K961446 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961446: AQ Hydrophilic Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961446
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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