510(k) · Cleared
ClearedDisposable Stone Extraction Basket
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Soudon Medical Technology Co., Ltd. · LQR Dislodger, Stone, Biliary
Cleared on Apr 3, 2026 as substantially equivalent to K201509 (Hangzhou AGS MedTech Co., Ltd., 2020) after a 193-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Apr 3, 2026
- Review
- 193 days
- Class
- Class II
- Product code
- LQR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K851965 (1985). No later device cites it as a predicate yet.
- Root · 3 generations backK851965 Wilson-Cook Stone ExtractorWilson-Cook Medical, Inc. · 1985
- 2 generations backK171969 Web II Memory Extraction Basket or Memory II Double Lumen Extraction…Wilson-Cook Medical, Inc. · 2018
- 1 generation backK201509 Disposable Stone Extraction basketHangzhou AGS MedTech Co., Ltd. · 2020
- This deviceK253056 Disposable Stone Extraction BasketZhejiang Soudon Medical Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K851965 | Wilson-Cook Stone Extractor | Wilson-Cook Medical, Inc. | 1985 | — |
| −2 | K171969 | Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket… | Wilson-Cook Medical, Inc. | 2018 | — |
| −1 | K201509 | Disposable Stone Extraction basket | Hangzhou AGS MedTech Co., Ltd. | 2020 | — |
| 0 (this device) | K253056 | Disposable Stone Extraction Basket | Zhejiang Soudon Medical Technology Co., Ltd. | 2026 | — |
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 LQR? 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 LQR device
- #1 K243807 Single Use Retrieval Basket V…score 9.9 · 4 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 |
|---|---|---|---|
| * | K201509 | Disposable Stone Extraction basketSummary page 5…on Basket Device Name Disposable Stone Extraction Basket Common Name: Disposable Stone Extraction Basket 510(k) Number K201509 Regulation Number: 876.5010 Regulation Name： Biliary Catheter and Accessories Regulatory Class:… | 2020 |
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 41 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All LQR devicesLQR Dislodger, Stone, Biliary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · LQR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LQR
248in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LQR
3in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LQR
111in 2025
MAUDE reports naming product code LQR, 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 | — | 0 | 23 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 2 | — | 3 | 28 |
| 2010 | 0 | — | 0 | 39 |
| 2011 | 0 | — | 0 | 47 |
| 2012 | 0 | — | 0 | 50 |
| 2013 | 1 | — | 0 | 13 |
| 2014 | 0 | — | 0 | 21 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 4 | 148 | 0 | 11 |
| 2018 | 3 | 248 | 0 | 43 |
| 2019 | 1 | — | 0 | 41 |
| 2020 | 1 | — | 0 | 51 |
| 2021 | 1 | — | 0 | 47 |
| 2022 | 0 | — | 0 | 58 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 2 | — | 0 | 69 |
| 2025 | 1 | — | 0 | 111 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The device is used for the endoscopic removal of biliary stones and foreign bodies in the biliary system.
The device is indicated for use in adult patient.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253056 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253056: Disposable Stone Extraction Basket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253056
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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