510(k) · Cleared
ClearedMicrovasive Insurg Helical & Mini-Helical Baskets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · LQR Dislodger, Stone, Biliary
Cleared on Dec 23, 1992 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Dec 23, 1992
- Review
- 51 days
- Class
- Class II
- Product code
- LQR
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK925495 Microvasive Insurg Helical & Mini-Helical BasketsBoston Scientific Corp · 1992
- Descendant · cites it directly · 3 of its ownK970121 Stone Dislodger, BasketBoston Scientific Corp · 1997
- Descendant · cites it directly · 3 of its ownK964937 A Lithotripter-Compatible BasketBoston Scientific Corp · 1997
- Descendant · 2 generations on · 2 of its ownK040447 Trapezoid RX Lithotripter Compatible Basket, Models 1086, 1087, 1088Boston Scientific Corp · 2004
- Descendant · 3 generations on · 1 of its ownK170811 Single Use Retrieval Nitinol Basket VOlympus Medical Systems Corp. · 2017
- Descendant · 4 generations on · 0 of its ownK243807 Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432POlympus Medical Systems Corp. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K970121Stone Dislodger, BasketBoston Scientific Corp · 1997 · cites it directly3descendants
- K964937A Lithotripter-Compatible BasketBoston Scientific Corp · 1997 · cites it directly3descendants
- K040447Trapezoid RX Lithotripter Compatible Basket, Models 1086, 1087, 1088Boston Scientific Corp · 2004 · 2 generations on2descendants
- K170811Single Use Retrieval Nitinol Basket VOlympus Medical Systems Corp. · 2017 · 3 generations on1descendant
- K243807Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432POlympus Medical Systems Corp. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925495 | Microvasive Insurg Helical & Mini-Helical Baskets | Boston Scientific Corp | 1992 | — |
| +1 | K970121 | Stone Dislodger, Basket | Boston Scientific Corp | 1997 | — |
| +1 | K964937 | A Lithotripter-Compatible Basket | Boston Scientific Corp | 1997 | — |
| +2 | K040447 | Trapezoid RX Lithotripter Compatible Basket, Models 1086, 1087, 1088 | Boston Scientific Corp | 2004 | — |
| +3 | K170811 | Single Use Retrieval Nitinol Basket V | Olympus Medical Systems Corp. | 2017 | — |
| +4 | K243807 | Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P | Olympus Medical Systems Corp. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K970121 (Boston Scientific Corp, 1997) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LQR devicesLQR Dislodger, Stone, Biliary: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K925495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925495: Microvasive Insurg Helical & Mini-Helical Baskets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925495
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026