510(k) · Cleared
ClearedEM-9000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elite Medical, Inc. · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Cleared on Mar 31, 2011 as substantially equivalent to K040476 (KARL STORZ Endoscopy-America, Inc., 2004) and 2 other predicates after a 307-day review. Its family tree reaches back 1 generation to 1984. 2 later devices descend from it.
- Decided
- Mar 31, 2011
- Review
- 307 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to P840008 (1984). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backP840008 Dornier Lithotripter Compact Transportable (DLCT)Dornier Medtech America, Inc. · 1984
- This deviceK101482 EM-9000Elite Medical, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK251562 OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG · 2025
- Descendant · cites it directly · 0 of its ownK131721 Extracorporeal Shock Wave Lithotripter, Comed Asadal-M1Comed Medical Systems Co., Ltd. · 2014
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 |
|---|---|---|---|---|---|
| −1 | P840008 | Dornier Lithotripter Compact Transportable (DLCT) | Dornier Medtech America, Inc. | 1984 | — |
| 0 (this device) | K101482 | EM-9000 | Elite Medical, Inc. | 2011 | — |
| +1 | K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n) | Ovesco Endoscopy AG | 2025 | — |
| +1 | K131721 | Extracorporeal Shock Wave Lithotripter, Comed Asadal-M1 | Comed Medical Systems Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K040476 | Storz Modulith, Model SLX-F2Summary page 1…21 CFR §876.5990 3. Predicate Devices The EM-9000 Extracorporeal Shock Wave Lithotripter is substantially equivalent to the following currently marketed devices: - K040476, Modulith SLX-F2, Karl Storz Endoscopy America Inc. - K070799, Modularis Variostar, Siemens Medical Solutions, Inc. - P840008,… | 2004 |
| * | K070799 | Modularis VariostarSummary page 1…rporeal Shock Wave Lithotripter is substantially equivalent to the following currently marketed devices: - K040476, Modulith SLX-F2, Karl Storz Endoscopy America Inc. - K070799, Modularis Variostar, Siemens Medical Solutions, Inc. - P840008, Compact Sigma, Dornier Medtech America Inc. 4. Descriptio… | 2007 |
| * | P840008 | Dornier Lithotripter Compact Transportable (DLCT)Summary page 1…e following currently marketed devices: - K040476, Modulith SLX-F2, Karl Storz Endoscopy America Inc. - K070799, Modularis Variostar, Siemens Medical Solutions, Inc. - P840008, Compact Sigma, Dornier Medtech America Inc. 4. Description of Device / Technological Characteristics The EM-9000 c… | 1984 |
What descends from it? (2)
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?
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. 2011, 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?
The EM-9000 Lithotripsy system is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101482 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101482: EM-9000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101482
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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