510(k) · Cleared
ClearedLithoVue System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · FGB Ureteroscope And Accessories, Flexible/Rigid
Cleared on Nov 13, 2015 as substantially equivalent to K060269 (Acmi Corporation, 2006) and 1 other predicate after a 24-day review. Its family tree reaches back 7 generations to 1993. 2 of the 49 devices in its family, counting itself, have a Class I recall. 24 later devices descend from it.
- Decided
- Nov 13, 2015
- Review
- 24 days
- Class
- Class II
- Product code
- FGB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K931154 (1993). 24 ancestors in all, the oldest K843084 (1985). 24 later devices descend from it, 7 citing it directly. 2 of the 49 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 6 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 5 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 4 generations backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- 3 generations backK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- 2 generations backK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
- 1 generation backK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- This deviceK153049 LithoVue SystemBoston Scientific Corporation · 2015
- Descendant · cites it directly · 9 of its ownK180367 Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. · 2018
- Descendant · cites it directly · 4 of its ownK221515 StoneSmart Connect Console, LithoVue Elite Single Use Digital…Boston Scientific Corporation · 2023
- Descendant · 2 generations on · 4 of its ownK201293 Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. · 2020
- Descendant · 2 generations on · 3 of its ownK233472 CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 2024 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK233645 StoneSmart Connect Console, LithoVue Elite Standard Deflection…Boston Scientific Corporation - · 2023 · Recalled
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 24 · See all- K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. · 2018 · cites it directly9descendants
- K221515StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope…Boston Scientific Corporation · 2023 · cites it directly4descendants
- K201293Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. · 2020 · 2 generations on4descendants
- K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 2024 · 2 generations on3descendants
- K233645StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse…Boston Scientific Corporation - · 2023 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −6 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −5 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −4 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| −3 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| −2 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
| −1 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| 0 (this device) | K153049 | LithoVue System | Boston Scientific Corporation | 2015 | — |
| +1 | K180367 | Ureterorenoscope System | Shanghai AnQing Medical Instrument Co., Ltd. | 2018 | — |
| +1 | K221515 | StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible… | Boston Scientific Corporation | 2023 | — |
| +2 | K201293 | Ureterorenoscope System | Shanghai AnQing Medical Instrument Co., Ltd. | 2020 | — |
| +2 | K233472 | CVAC Aspiration System + CVAC Image Processor | Calyxo, Inc. | 2024 | Class I |
| +2 | K233645 | StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite… | Boston Scientific Corporation - | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1991 | 2 | 1 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 1 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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.
2 devices in this family have a Class I recall. 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 FGB device
- #1 K251951 Single-Use Video Flexible Ureterorenoscope…score 16.2 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope SystemSummary page 4…d Classification: FGB – Endoscope, associated accessories 21 CFR 876.1500, Class II Premarket Notification: ACMI, K060269 and Trade name: Olympus URF-V (cleared as the Video Ureteroscope,… | 2006 |
| * | K033651 | Olympus Video Ureteroscope, NTSCSummary page 5…Pg. 2 of 3 LithoVue System Boston Scientific Traditional 510(k) Premarket Notification: Olympus, K033651 F. Device Description The LithoVue™ System is a software-controlled digital flexible ureteroscope system that consis… | 2004 |
What descends from it? (24)
See all 247 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180367 | Ureterorenoscope System | 2018 | 9 |
| K221515 | StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope… | 2023 | 4 |
| K211347 | Uretero1 Ureteroscope System | 2021 | 3 |
| K233630 | Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse… | 2024 | 1 |
| K233275 | RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use… | 2024 | 0 |
| K223097 | RenaNav Ureteroscope System | 2023 | 0 |
| K213334 | Monarch Platform, Urology | 2022 | 0 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 5 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
- K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 2024 · 2 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 24 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K180367 (Shanghai AnQing Medical Instrument Co., Ltd., 2018) has gone furthest, with 9 descendants of its own.
- 6 other devices also cite its predicate K060269.
How does its category compare?
All FGB devicesFGB Ureteroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · FGB
17in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGB
134in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGB
15in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGB
1,307in 2025
MAUDE reports naming product code FGB, 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 | — | 0 | 6 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 1 | — | 0 | 8 |
| 2014 | 2 | — | 0 | 12 |
| 2015 | 1 | — | 0 | 16 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 2 | — | 0 | 142 |
| 2018 | 4 | 191 | 0 | 118 |
| 2019 | 2 | — | 0 | 207 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 3 | 191 | 0 | 325 |
| 2022 | 5 | 205 | 4 | 455 |
| 2023 | 8 | 183 | 1 | 458 |
| 2024 | 16 | 217 | 15 | 572 |
| 2025 | 17 | 134 | 0 | 1,307 |
| 2026 | 9 | 140 | 1 | — |
What is it indicated for?
The LithoVue System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153049 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153049: LithoVue System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153049
Report an extraction error
Are you the manufacturer?
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