510(k) · Cleared
ClearedWell Lead Ureteral Access Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well Lead Medical Co., Ltd. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Jan 7, 2016 as substantially equivalent to K123675 (Coloplast A/S, 2013) and 1 other predicate after a 260-day review. Its family tree reaches back 3 generations to 2002. 19 later devices descend from it.
- Decided
- Jan 7, 2016
- Review
- 260 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K022135 (2002). 6 ancestors in all. 19 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK022135 Ureteral Access Sheath Set (Uass)Boston Scientific Corp · 2002
- 2 generations backK122649 Navigator HD Ureteral Access Sheath SetBoston Scientific Corp · 2012
- 1 generation backK140323 Navigator HD Ureteral Access Sheath SetsBoston Scientific · 2014
- This deviceK151084 Well Lead Ureteral Access SheathWell Lead Medical Co., Ltd. · 2016
- Descendant · cites it directly · 7 of its ownK161110 ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016
- Descendant · cites it directly · 5 of its ownK230748 Disposable Ureteral Access SheathYoucare Technology Co.,Ltd. (Wuhan) · 2023
- Descendant · cites it directly · 4 of its ownK203165 Disposable Ureteral Access SheathSuzhou Beyo Medical Technology Co., Ltd. · 2021
- Descendant · 2 generations on · 2 of its ownK241181 Disposable Ureteral Guide SheathDongguan Zsr Biomedical Technology Company Limited · 2024
- Descendant · 2 generations on · 1 of its ownK243710 Disposable ureteral access sheathShenzhen Trious Medical Technology Co., Ltd. · 2025
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016 · cites it directly7descendants
- K230748Disposable Ureteral Access SheathYoucare Technology Co.,Ltd. (Wuhan) · 2023 · cites it directly5descendants
- K203165Disposable Ureteral Access SheathSuzhou Beyo Medical Technology Co., Ltd. · 2021 · cites it directly4descendants
- K241181Disposable Ureteral Guide SheathDongguan Zsr Biomedical Technology Company Limited · 2024 · 2 generations on2descendants
- K243710Disposable ureteral access sheathShenzhen Trious Medical Technology Co., Ltd. · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K022135 | Ureteral Access Sheath Set (Uass) | Boston Scientific Corp | 2002 | — |
| −2 | K122649 | Navigator HD Ureteral Access Sheath Set | Boston Scientific Corp | 2012 | — |
| −1 | K140323 | Navigator HD Ureteral Access Sheath Sets | Boston Scientific | 2014 | — |
| 0 (this device) | K151084 | Well Lead Ureteral Access Sheath | Well Lead Medical Co., Ltd. | 2016 | — |
| +1 | K161110 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | 2016 | — |
| +1 | K230748 | Disposable Ureteral Access Sheath | Youcare Technology Co.,Ltd. (Wuhan) | 2023 | — |
| +1 | K203165 | Disposable Ureteral Access Sheath | Suzhou Beyo Medical Technology Co., Ltd. | 2021 | — |
| +2 | K241181 | Disposable Ureteral Guide Sheath | Dongguan Zsr Biomedical Technology Company Limited | 2024 | — |
| +2 | K243710 | Disposable ureteral access sheath | Shenzhen Trious Medical Technology 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 8 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K123675 | RE-Trace Ureteral Access Sheath, 10/12 French, Length 35 and 45 CM, Ureteral Access…Summary page 4…ing the passage of endoscopes and other instruments into the urinary tract. Predicate Device(s): K123675-Re-Trace Ureteral Access Sheath K140323-NavigatorTM HID Ureteral Access Sheath Set Traditional… | 2013 |
| * | K140323 | Navigator HD Ureteral Access Sheath SetsSummary page 4…instruments into the urinary tract. Predicate Device(s): K123675-Re-Trace Ureteral Access Sheath K140323-NavigatorTM HID Ureteral Access Sheath Set Traditional 510(k) for Well Lead Ureteral Access Sheath… | 2014 |
What descends from it? (19)
See all 193 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K161110 (Well Lead Medical Co., Ltd., 2016) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K123675.
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. 2016, 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 Well Lead Ureteral Access Sheath is used 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/K151084 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151084: Well Lead Ureteral Access Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151084
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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