510(k) · Cleared
ClearedMicrovasive (R) Monolith (TM) Mechanical Lithotriptor
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 Aug 29, 1994 after a 55-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Aug 29, 1994
- Review
- 55 days
- Class
- Class II
- Product code
- LQC
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK943191 Microvasive (R) Monolith (TM) Mechanical LithotriptorBoston Scientific Corp · 1994
- 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
Most influential descendants
Showing 4 of 4 · See all- 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) | K943191 | Microvasive (R) Monolith (TM) Mechanical Lithotriptor | Boston Scientific Corp | 1994 | — |
| +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 | 1 | 0 |
| 2004 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K964937 | A Lithotripter-Compatible Basket | 1997 | 3 |
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, K964937 (Boston Scientific Corp, 1997) has gone furthest, with 3 descendants 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 | — |
https://510kreport.com/device/K943191 · printed Nov 5, 2026
Cite this page
510(k) Report. “K943191: Microvasive (R) Monolith (TM) Mechanical Lithotriptor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K943191
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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