510(k) · Cleared
ClearedDisposable Stone Extraction basket
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou AGS MedTech Co., Ltd. · LQR Dislodger, Stone, Biliary
Cleared on Dec 16, 2020 as substantially equivalent to K171969 (Wilson-Cook Medical, Inc., 2018) after a 194-day review. Its family tree reaches back 2 generations to 1985. 1 later device descends from it.
- Decided
- Dec 16, 2020
- Review
- 194 days
- Class
- Class II
- Product code
- LQR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K851965 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK851965 Wilson-Cook Stone ExtractorWilson-Cook Medical, Inc. · 1985
- 1 generation backK171969 Web II Memory Extraction Basket or Memory II Double Lumen Extraction…Wilson-Cook Medical, Inc. · 2018
- This deviceK201509 Disposable Stone Extraction basketHangzhou AGS MedTech Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK253056 Disposable Stone Extraction BasketZhejiang Soudon Medical Technology Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253056Disposable Stone Extraction BasketZhejiang Soudon 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 |
|---|---|---|---|---|---|
| −2 | K851965 | Wilson-Cook Stone Extractor | Wilson-Cook Medical, Inc. | 1985 | — |
| −1 | K171969 | Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket… | Wilson-Cook Medical, Inc. | 2018 | — |
| 0 (this device) | K201509 | Disposable Stone Extraction basket | Hangzhou AGS MedTech Co., Ltd. | 2020 | — |
| +1 | K253056 | Disposable Stone Extraction Basket | Zhejiang Soudon Medical Technology Co., Ltd. | 2026 | — |
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 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 K253056 Disposable Stone Extraction Basketscore 11.7 · 3 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 |
|---|---|---|---|
| * | K171969 | Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5…Summary page 5…Y BASKET 5F SOFT WIRE Device Name: MEMORY BASKET 5F SOFT WIRE Common Name: Non-Lithotripsy Extraction Basket 510(k) Number: K171969 Regulation class: Class II Regulation Number: 876.5010 Regulation Description: Biliary Catheter and Acc… | 2018 |
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 |
|---|---|---|---|
| K253056 | Disposable Stone Extraction Basket | 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 35 years and passes through 2 companies; a new generation was cleared every 32.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K253056 (Zhejiang Soudon Medical Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K171969.
How does its category compare?
All LQR devicesLQR Dislodger, Stone, Biliary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 fbreign bodies.
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/K201509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201509: Disposable Stone Extraction basket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201509
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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