510(k) · Cleared
ClearedDisposable Ureteral Access Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou Beyo Medical Technology Co., Ltd. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Apr 30, 2021 as substantially equivalent to K151084 (Well Lead Medical Co., Ltd., 2016) after a 189-day review. Its family tree reaches back 4 generations to 2002. 4 later devices descend from it.
- Decided
- Apr 30, 2021
- Review
- 189 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K022135 (2002). 7 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK022135 Ureteral Access Sheath Set (Uass)Boston Scientific Corp · 2002
- 3 generations backK122649 Navigator HD Ureteral Access Sheath SetBoston Scientific Corp · 2012
- 2 generations backK140323 Navigator HD Ureteral Access Sheath SetsBoston Scientific · 2014
- 1 generation backK151084 Well Lead Ureteral Access SheathWell Lead Medical Co., Ltd. · 2016
- This deviceK203165 Disposable Ureteral Access SheathSuzhou Beyo Medical Technology Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK240167 Single-use Ureteral Access SheathHunan Vathin Medical Instrument Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK220065 Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK260410 Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK251599 Single-use Ureteral Access SheathHunan Vathin Medical Instrument Co., Ltd. · 2025
Most influential descendants
Showing 4 of 4 · See all- K240167Single-use Ureteral Access SheathHunan Vathin Medical Instrument Co., Ltd. · 2024 · cites it directly1descendant
- K220065Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd. · 2022 · cites it directly1descendant
- K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K251599Single-use Ureteral Access SheathHunan Vathin Medical Instrument Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K022135 | Ureteral Access Sheath Set (Uass) | Boston Scientific Corp | 2002 | — |
| −3 | K122649 | Navigator HD Ureteral Access Sheath Set | Boston Scientific Corp | 2012 | — |
| −2 | K140323 | Navigator HD Ureteral Access Sheath Sets | Boston Scientific | 2014 | — |
| −1 | K151084 | Well Lead Ureteral Access Sheath | Well Lead Medical Co., Ltd. | 2016 | — |
| 0 (this device) | K203165 | Disposable Ureteral Access Sheath | Suzhou Beyo Medical Technology Co., Ltd. | 2021 | — |
| +1 | K240167 | Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument Co., Ltd. | 2024 | — |
| +1 | K220065 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022 | — |
| +2 | K260410 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2026 | — |
| +1 | K251599 | Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 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 |
|---|---|---|---|
| * | K151084 | Well Lead Ureteral Access SheathSummary page 4…AS-1255, BY-AS-1425, BY- AS-1435, BY-AS-1440, BY-AS-1445, BY-AS-1455. 3. PREDICATE DEVICE Product Name: Well Lead UreteralAccess Sheath 510(k) Number: K151084 This predicate has not been subject to a design-related recall. No reference devices were used in this submission. 4.… | 2016 |
What descends from it? (4)
3 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 19 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K240167 (Hunan Vathin Medical Instrument Co., Ltd., 2024) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K151084.
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. 2021, 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 Ureteral Access Sheath is intended to use in urologic endoscopic procedures to facilitate the passage of endoscopes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203165 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203165: Disposable 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/K203165
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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