510(k) · Cleared
Recalled · Class II · 2015Modularis Variostar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Cleared on Nov 1, 2007 after a 223-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled once.
- Decided
- Nov 1, 2007
- Review
- 223 days
- Class
- Class II
- Product code
- LNS
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK070799 Modularis VariostarSiemens Medical Solutions USA, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK101482 EM-9000Elite Medical, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK251562 OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG · 2025
- Descendant · 2 generations on · 0 of its ownK131721 Extracorporeal Shock Wave Lithotripter, Comed Asadal-M1Comed Medical Systems Co., Ltd. · 2014
Most influential descendants
Showing 3 of 3 · See all- K101482EM-9000Elite Medical, Inc. · 2011 · cites it directly2descendants
- K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG · 2025 · 2 generations on0descendants
- K131721Extracorporeal Shock Wave Lithotripter, Comed Asadal-M1Comed Medical Systems Co., Ltd. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070799 | Modularis Variostar | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +1 | K101482 | EM-9000 | Elite Medical, Inc. | 2011 | — |
| +2 | K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n) | Ovesco Endoscopy AG | 2025 | — |
| +2 | K131721 | Extracorporeal Shock Wave Lithotripter, Comed Asadal-M1 | Comed Medical Systems Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 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 LNS? 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 LNS device
- #1 K252913 Break Wavescore 15.5 · 7 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 |
|---|---|---|---|
| * | — | LITHOSTAR Modularis Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101482 | EM-9000 | 2011 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 24, 2015 | Class II | Z-0265-2016 | Software design | Display freeze of MODULARIS hand control results in information not being updated on the display. Current treatment data is not shown to the user. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K101482 (Elite Medical, Inc., 2011) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LNS devicesLNS Lithotriptor, Extracorporeal Shock-Wave, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LNS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNS
111in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNS
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LNS
61in 2025
MAUDE reports naming product code LNS, 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 | 4 | 146 | 0 | 4 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 15 |
| 2011 | 3 | 307 | 0 | 21 |
| 2012 | 3 | 111 | 0 | 20 |
| 2013 | 2 | — | 0 | 18 |
| 2014 | 2 | — | 0 | 21 |
| 2015 | 2 | — | 1 | 22 |
| 2016 | 0 | — | 0 | 50 |
| 2017 | 2 | — | 0 | 54 |
| 2018 | 0 | — | 0 | 59 |
| 2019 | 0 | — | 0 | 60 |
| 2020 | 1 | — | 0 | 38 |
| 2021 | 1 | — | 0 | 55 |
| 2022 | 0 | — | 0 | 52 |
| 2023 | 2 | — | 0 | 86 |
| 2024 | 0 | — | 0 | 40 |
| 2025 | 1 | — | 0 | 61 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
MODULARIS Variostar is a lithotripter device designed to treat urolithiasis with extracorporeal shock wave lithotripsy (ESWL) when used as part of the modular platform, MODULARIS. The device may be used in two separate configurations. Both configurations are designed to support urologic procedures within the scope of urolithiasis and may be used in a mobile-use environment. Each configuration includes: the lithotripter MODULARIS Variostar with shockwave…
Read the full statement (153 words)
MODULARIS Variostar is a lithotripter device designed to treat urolithiasis with extracorporeal shock wave lithotripsy (ESWL) when used as part of the modular platform, MODULARIS.
The device may be used in two separate configurations. Both configurations are designed to support urologic procedures within the scope of urolithiasis and may be used in a mobile-use environment.
Each configuration includes: the lithotripter MODULARIS Variostar with shockwave head Cplus, a patient table, and an ECG device.
One configuration would include a mobile C-arm to provide the imaging and positioning of the shockwave focus to the urinary tract stones. This configuration may be used to treat renal calyceal stones, renal pelvis stones, and ureteral stones.
A second configuration would include an ultrasound system to provide the imaging and positioning of the shockwave focus to the urinary tract stones. For this configuration, the indication for use is limited to the fragmentation of kidney and upper ureteral stones only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070799 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070799: Modularis Variostar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070799
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