510(k) · Cleared
ClearedUreteral Access Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang YiGao Medical Technology Co., Ltd. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Sep 5, 2025 as substantially equivalent to K172217 (Cook Incorporated, 2017) after a 231-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Sep 5, 2025
- Review
- 231 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K990775 (1999). 10 ancestors in all, the oldest K961904 (1996). No later device cites it as a predicate yet.
- Root · 4 generations backK990775 Ureteral Access Sheath SetApplied Medical Resources · 1999
- 3 generations backK993650 Ureteral Access Sheath Set - New ModelsApplied Medical Resources · 1999
- 2 generations backK043418 Cook Pediatric Flexor Ureteral Access ShealthCook Urological, Inc. · 2005 · Recalled
- 1 generation backK172217 Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release…Cook Incorporated · 2017
- This deviceK250132 Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K990775 | Ureteral Access Sheath Set | Applied Medical Resources | 1999 | — |
| −3 | K993650 | Ureteral Access Sheath Set - New Models | Applied Medical Resources | 1999 | — |
| −2 | K043418 | Cook Pediatric Flexor Ureteral Access Shealth | Cook Urological, Inc. | 2005 | 1 |
| −1 | K172217 | Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral… | Cook Incorporated | 2017 | — |
| 0 (this device) | K250132 | Ureteral Access Sheath | Zhejiang YiGao Medical Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 3 | 0 |
| 2010 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K172217 | Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathSummary page 5…Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code I K172217 Flexor@ Ureteral Access SheathFlexor@ Parallel" Rapid Releaj FED Device Descri… | 2017 |
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 26 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 1 other device also cites its predicate K172217.
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 ureteral access sheath is used to establish a working channel during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract. The intended population of this device should be adult only.
This is a single-use device. A re-sterilization by users and re-use of the device are not allowed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250132 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250132: 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/K250132
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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