510(k) · Cleared
ClearedTrapezoid RX Lithotripter Compatible Basket, Models 1086, 1087, 1088
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · LQC Lithotriptor, Biliary Mechanical
Cleared on Mar 12, 2004 as substantially equivalent to K964937 (Boston Scientific Corp, 1997) after a 21-day review. Its family tree reaches back 2 generations to 1992. 2 later devices descend from it.
- Decided
- Mar 12, 2004
- Review
- 21 days
- Class
- Class II
- Product code
- LQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K925495 (1992). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK925495 Microvasive Insurg Helical & Mini-Helical BasketsBoston Scientific Corp · 1992
- 1 generation backK964937 A Lithotripter-Compatible BasketBoston Scientific Corp · 1997
- This deviceK040447 Trapezoid RX Lithotripter Compatible Basket, Models 1086, 1087, 1088Boston Scientific Corp · 2004
- Descendant · cites it directly · 1 of its ownK170811 Single Use Retrieval Nitinol Basket VOlympus Medical Systems Corp. · 2017
- Descendant · 2 generations on · 0 of its ownK243807 Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432POlympus Medical Systems Corp. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925495 | Microvasive Insurg Helical & Mini-Helical Baskets | Boston Scientific Corp | 1992 | — |
| −1 | K964937 | A Lithotripter-Compatible Basket | Boston Scientific Corp | 1997 | — |
| 0 (this device) | 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 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2025 | 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 LQC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K964937 | A Lithotripter-Compatible BasketSummary page 1…1I per 21 CFR Part 876, Section 4500 PREDICATE DEVICE: Boston Scientific Lithotripter Compatible Basket (LCB) (K964937) and the Cook® Memory Soft Wire Basket DESCRIPTION: The Boston Scientific Lithotripter Compatible Basket… | 1997 |
| * | — | Cook® Memory Soft Wire Basket Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170811 | Single Use Retrieval Nitinol Basket V | 2017 | 1 |
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 12 years and passes through 1 company; a new generation was cleared every 7.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K170811 (Olympus Medical Systems Corp., 2017) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LQC devicesLQC Lithotriptor, Biliary Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LQC
FDA has decided no LQC device since 2007.
Median 510(k) review, days · LQC
Too few LQC 510(k)s in any year since 2007 to give a median.
Recalls per year · LQC
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LQC
127in 2025
MAUDE reports naming product code LQC, 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 | 0 | — | 4 | 40 |
| 2008 | 0 | — | 0 | 124 |
| 2009 | 0 | — | 0 | 141 |
| 2010 | 0 | — | 0 | 116 |
| 2011 | 0 | — | 0 | 112 |
| 2012 | 0 | — | 0 | 64 |
| 2013 | 0 | — | 0 | 85 |
| 2014 | 0 | — | 0 | 98 |
| 2015 | 0 | — | 0 | 137 |
| 2016 | 0 | — | 0 | 157 |
| 2017 | 0 | — | 0 | 145 |
| 2018 | 0 | — | 0 | 84 |
| 2019 | 0 | — | 0 | 123 |
| 2020 | 0 | — | 0 | 164 |
| 2021 | 0 | — | 2 | 112 |
| 2022 | 0 | — | 0 | 245 |
| 2023 | 0 | — | 0 | 224 |
| 2024 | 0 | — | 1 | 301 |
| 2025 | 0 | — | 0 | 127 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Boston Scientific Lithotripter Compatible Basket is indicated for use in the retrieval of stones from the biliary system and endoscopic crushing (lilhotripsy) of biliary calculi. The Lithotripter Compatible Basket should not be used for any purpose other than its intended application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040447 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040447: Trapezoid RX Lithotripter Compatible Basket, Models 1086, 1087, 1088.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040447
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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