510(k) · Cleared
ClearedSingle Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · LQR Dislodger, Stone, Biliary
Cleared on Mar 18, 2025 as substantially equivalent to K170811 (Olympus Medical Systems Corp., 2017) after a 97-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Mar 18, 2025
- Review
- 97 days
- Class
- Class II
- Product code
- LQR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K925495 (1992). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK925495 Microvasive Insurg Helical & Mini-Helical BasketsBoston Scientific Corp · 1992
- 3 generations backK964937 A Lithotripter-Compatible BasketBoston Scientific Corp · 1997
- 2 generations backK040447 Trapezoid RX Lithotripter Compatible Basket, Models 1086, 1087, 1088Boston Scientific Corp · 2004
- 1 generation backK170811 Single Use Retrieval Nitinol Basket VOlympus Medical Systems Corp. · 2017
- This deviceK243807 Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432POlympus Medical Systems Corp. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K925495 | Microvasive Insurg Helical & Mini-Helical Baskets | Boston Scientific Corp | 1992 | — |
| −3 | K964937 | A Lithotripter-Compatible Basket | Boston Scientific Corp | 1997 | — |
| −2 | K040447 | Trapezoid RX Lithotripter Compatible Basket, Models 1086, 1087, 1088 | Boston Scientific Corp | 2004 | — |
| −1 | K170811 | Single Use Retrieval Nitinol Basket V | Olympus Medical Systems Corp. | 2017 | — |
| 0 (this device) | K243807 | Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P | Olympus Medical Systems Corp. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 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 |
|---|---|---|---|
| * | K170811 | Single Use Retrieval Nitinol Basket VSummary page 5…OCZ Device Classification 2 III. Predicate Device Substantial equivalence is claimed to the following device: • Single Use Retrieval Nitinol Basket V, K170811, Olympus Medical Systems Corp. The following device is cited as a reference device: • Memory Baskets, K171969, Wilson-Cook Me… | 2017 |
| † | K171969 | Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5… | 2018 |
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 33 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- None of the 6 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. 2025, 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 Retrieval Basket V FG-V421PR/FG-V422PR/FG-V431P/FG-V432P are intended to be used to retrieve stones from the biliary tract in combination with an endoscope.
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/K243807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243807: Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243807
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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