510(k) · Cleared
ClearedSingle-use Extraction Baskets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scivita Medical Technology Co., Ltd. · LQR Dislodger, Stone, Biliary
Cleared on Oct 15, 2024 as substantially equivalent to K203322 (Boston Scientific Corporation, 2021) after a 265-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Oct 15, 2024
- Review
- 265 days
- Class
- Class II
- Product code
- LQR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K902944 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK902944 Wittich Nitinol Stone BasketCook, Inc. · 1990
- 2 generations backK173009 NCompass Nitinol Stone ExtractorsCook Incorporated · 2017 · Recalled
- 1 generation backK203322 SpyGlass Discover Retrieval BasketBoston Scientific Corporation · 2021
- This deviceK240192 Single-use Extraction BasketsScivita Medical Technology Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902944 | Wittich Nitinol Stone Basket | Cook, Inc. | 1990 | — |
| −2 | K173009 | NCompass Nitinol Stone Extractors | Cook Incorporated | 2017 | 1 |
| −1 | K203322 | SpyGlass Discover Retrieval Basket | Boston Scientific Corporation | 2021 | — |
| 0 (this device) | K240192 | Single-use Extraction Baskets | Scivita Medical Technology Co., Ltd. | 2024 | — |
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 |
|---|---|---|---|
| * | K203322 | SpyGlass Discover Retrieval BasketSummary page 6…876.5010 Product Code(s) LQR | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K203322 SpyGlass™ Discover Retrieval Basket LQR Device Description Summary 21 CFR 807.92(a)(4) The Single-use Extraction Baskets is a si… | 2021 |
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 34 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All LQR devicesLQR Dislodger, Stone, Biliary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Single-use Extraction Baskets is intended for the endoscopic removal of stones and stone fragments in the biliary system.
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/K240192 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240192: Single-use Extraction Baskets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240192
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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