510(k) · Cleared
Recalled · Class II · 2021Kwart Retro-Inject Ureteral Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · FAD Stent, Ureteral
Cleared on Jun 7, 2017 as substantially equivalent to K010002 (Boston Scientific Corp, 2001) and 1 other predicate after a 313-day review. Its family tree reaches back 1 generation to 1994. It has been recalled once.
- Decided
- Jun 7, 2017
- Review
- 313 days
- Class
- Class II
- Product code
- FAD
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K924608 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK924608 Hydrogel Coated Percuflex (R) Drainage CathetersBoston Scientific Corp · 1994
- This deviceK162109 Kwart Retro-Inject Ureteral StentCook Incorporated · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924608 | Hydrogel Coated Percuflex (R) Drainage Catheters | Boston Scientific Corp | 1994 | — |
| 0 (this device) | K162109 | Kwart Retro-Inject Ureteral Stent | Cook Incorporated | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (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 |
|---|---|---|---|
| * | K010002 | Contour Polaris Ureteral StentSummary page 4…Class II, Gastroenterology/Urology Predicate Device: The primary predicate device is the Contour™ and Contour VL™ Injection Ureteral Stent Set cleared under 510(k) K010002. The secondary predicate device is the Boston Scientific Hydrogel Coated Percuflex Drainage Catheter cleared under K924608. Devi… | 2001 |
| * | K924608 | Hydrogel Coated Percuflex (R) Drainage CathetersSummary page 4…ection Ureteral Stent Set cleared under 510(k) K010002. The secondary predicate device is the Boston Scientific Hydrogel Coated Percuflex Drainage Catheter cleared under K924608. Device Description: The Kwart Retro-Inject™ Stent Set is intended to be marketed as a set with multiple components. The set is… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 4, 2021 | Class II | Z-0960-2021 | Nonconforming Material/Component | Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K010002.
How does its category compare?
All FAD devicesFAD Stent, Ureteral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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?
Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent post- E.S.W.L.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162109: Kwart Retro-Inject Ureteral Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162109
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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