510(k) · Cleared
ClearedSingle Use Ureteral Access Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Chuangxiang Medical Technology Co., Ltd. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on May 25, 2022 as substantially equivalent to K203165 (Suzhou Beyo Medical Technology Co., Ltd., 2021) after a 135-day review. Its family tree reaches back 5 generations to 2002. 1 later device descends from it.
- Decided
- May 25, 2022
- Review
- 135 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K022135 (2002). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK022135 Ureteral Access Sheath Set (Uass)Boston Scientific Corp · 2002
- 4 generations backK122649 Navigator HD Ureteral Access Sheath SetBoston Scientific Corp · 2012
- 3 generations backK140323 Navigator HD Ureteral Access Sheath SetsBoston Scientific · 2014
- 2 generations backK151084 Well Lead Ureteral Access SheathWell Lead Medical Co., Ltd. · 2016
- 1 generation backK203165 Disposable Ureteral Access SheathSuzhou Beyo Medical Technology Co., Ltd. · 2021
- This deviceK220065 Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK260410 Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K022135 | Ureteral Access Sheath Set (Uass) | Boston Scientific Corp | 2002 | — |
| −4 | K122649 | Navigator HD Ureteral Access Sheath Set | Boston Scientific Corp | 2012 | — |
| −3 | K140323 | Navigator HD Ureteral Access Sheath Sets | Boston Scientific | 2014 | — |
| −2 | K151084 | Well Lead Ureteral Access Sheath | Well Lead Medical Co., Ltd. | 2016 | — |
| −1 | K203165 | Disposable Ureteral Access Sheath | Suzhou Beyo Medical Technology Co., Ltd. | 2021 | — |
| 0 (this device) | K220065 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022 | — |
| +1 | K260410 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2026 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K203165 | Disposable Ureteral Access SheathSummary page 4…: Endoscope and accessories Regulation class: II Regulation number: 876.1500 Panel: Gastroenterology/Urology Product code: FED 4. Predicative device 4.1) 510(k) Number: K203165 Device Name: Disposable Ureteral Access Sheath 5. Device description The Single Use Ureteral Access Sheath is a single use steri… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260410 | Single Use Ureteral Access Sheath | 2026 | 0 |
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 20 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K260410 (Zhejiang Chuangxiang Medical Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K203165.
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. 2022, 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 device 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/K220065 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220065: Single Use 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/K220065
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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