510(k) · Cleared
ClearedLumenaTM Ureteral Access Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cathegenix (Xiamen) Co., Ltd. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Jun 27, 2025 as substantially equivalent to K241181 (Dongguan Zsr Biomedical Technology Company Limited, 2024) after a 120-day review. Its family tree reaches back 6 generations to 2002.
- Decided
- Jun 27, 2025
- Review
- 120 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K022135 (2002). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK022135 Ureteral Access Sheath Set (Uass)Boston Scientific Corp · 2002
- 5 generations backK122649 Navigator HD Ureteral Access Sheath SetBoston Scientific Corp · 2012
- 4 generations backK140323 Navigator HD Ureteral Access Sheath SetsBoston Scientific · 2014
- 3 generations backK151084 Well Lead Ureteral Access SheathWell Lead Medical Co., Ltd. · 2016
- 2 generations backK230748 Disposable Ureteral Access SheathYoucare Technology Co.,Ltd. (Wuhan) · 2023
- 1 generation backK241181 Disposable Ureteral Guide SheathDongguan Zsr Biomedical Technology Company Limited · 2024
- This deviceK250585 LumenaTM Ureteral Access SheathCathegenix (Xiamen) Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K022135 | Ureteral Access Sheath Set (Uass) | Boston Scientific Corp | 2002 | — |
| −5 | K122649 | Navigator HD Ureteral Access Sheath Set | Boston Scientific Corp | 2012 | — |
| −4 | K140323 | Navigator HD Ureteral Access Sheath Sets | Boston Scientific | 2014 | — |
| −3 | K151084 | Well Lead Ureteral Access Sheath | Well Lead Medical Co., Ltd. | 2016 | — |
| −2 | K230748 | Disposable Ureteral Access Sheath | Youcare Technology Co.,Ltd. (Wuhan) | 2023 | — |
| −1 | K241181 | Disposable Ureteral Guide Sheath | Dongguan Zsr Biomedical Technology Company Limited | 2024 | — |
| 0 (this device) | K250585 | LumenaTM Ureteral Access Sheath | Cathegenix (Xiamen) Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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 FED? 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 FED device
- #1 K241181 Disposable Ureteral Guide Sheathscore 15.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K241181 | Disposable Ureteral Guide SheathSummary page 5…tion: 21 CFR 876.1500 Product Code: FED Device Class: 2 3. Identification of Predicate Devices Disposable Ureteral Guide Sheath cleared under K241181. 4. Intended Use/Indications for Use The ureteral access sheath is indicated to establish a conduit during endoscopic urologica… | 2024 |
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?
- The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K241181.
How does its category compare?
All FED devicesFED Endoscopic Access Overtube, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · FED
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FED
120in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FED
4in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · FED
115in 2025
MAUDE reports naming product code FED, 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 | 14 |
| 2008 | 1 | — | 0 | 18 |
| 2009 | 4 | 90 | 0 | 19 |
| 2010 | 3 | 90 | 0 | 19 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 4 | 82 | 0 | 35 |
| 2013 | 2 | — | 3 | 25 |
| 2014 | 4 | 123 | 0 | 34 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 5 | 126 | 0 | 29 |
| 2017 | 1 | — | 0 | 32 |
| 2018 | 4 | 122 | 0 | 34 |
| 2019 | 5 | 94 | 0 | 30 |
| 2020 | 4 | 117 | 0 | 33 |
| 2021 | 3 | 189 | 0 | 55 |
| 2022 | 1 | — | 0 | 36 |
| 2023 | 3 | 138 | 0 | 53 |
| 2024 | 6 | 98 | 4 (4) | 64 |
| 2025 | 11 | 120 | 0 | 115 |
| 2026 | 6 | 67 | 0 | — |
What is it indicated for?
The LumenaTM Ureteral Access Sheath is indicated to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250585 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250585: LumenaTM Ureteral Access Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250585
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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