510(k) · Cleared
ClearedLite-Med LM-9200 Elma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lite-Med, Inc. · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Cleared on Sep 28, 2011 as substantially equivalent to K002929 (Dornier Medtech America, Inc., 2001) and 2 other predicates after a 331-day review. Its family tree reaches back 3 generations to 1997. 4 later devices descend from it.
- Decided
- Sep 28, 2011
- Review
- 331 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to P970019 (1997). 7 ancestors in all, the oldest P840008 (1984). 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backP970019 Healthtronics Lithotron Lihtotripsy SystemHealthtronics Surgical Services, Inc. · 1997
- 2 generations backK040461 Econolith E3000, Model 3000 (SW-6)Medispec, Ltd. · 2004
- 1 generation backK063504 Econolith EM1000Medispec, Ltd. · 2007
- This deviceK103217 Lite-Med LM-9200 ElmaLite-Med, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK142561 LM-9300 ELMA LithotripterLite-Med, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK242922 Extracorporeal Shock Wave Lithotripter (U200)Shenzhen Wikkon Precision Technologies Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK201001 Modulith SLX-F2Karl Storz Endoscopy America · 2021
- Descendant · cites it directly · 0 of its ownK131721 Extracorporeal Shock Wave Lithotripter, Comed Asadal-M1Comed Medical Systems Co., Ltd. · 2014
Most influential descendants
Showing 4 of 4 · See all- K142561LM-9300 ELMA LithotripterLite-Med, Inc. · 2015 · cites it directly1descendant
- K242922Extracorporeal Shock Wave Lithotripter (U200)Shenzhen Wikkon Precision Technologies Co., Ltd. · 2025 · cites it directly0descendants
- K201001Modulith SLX-F2Karl Storz Endoscopy America · 2021 · 2 generations on0descendants
- K131721Extracorporeal Shock Wave Lithotripter, Comed Asadal-M1Comed Medical Systems Co., Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P970019 | Healthtronics Lithotron Lihtotripsy System | Healthtronics Surgical Services, Inc. | 1997 | — |
| −2 | K040461 | Econolith E3000, Model 3000 (SW-6) | Medispec, Ltd. | 2004 | — |
| −1 | K063504 | Econolith EM1000 | Medispec, Ltd. | 2007 | — |
| 0 (this device) | K103217 | Lite-Med LM-9200 Elma | Lite-Med, Inc. | 2011 | — |
| +1 | K142561 | LM-9300 ELMA Lithotripter | Lite-Med, Inc. | 2015 | — |
| +1 | K242922 | Extracorporeal Shock Wave Lithotripter (U200) | Shenzhen Wikkon Precision Technologies Co., Ltd. | 2025 | — |
| +2 | K201001 | Modulith SLX-F2 | Karl Storz Endoscopy America | 2021 | — |
| +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 |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K002929 | Dornier Compact Alpha LithotripterSummary page 1…MA is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices like Dornier Compact Alpha Lithotripter (K002929), Siemens Lithoskop (KO'70665) and Medispec Econolith EM 1000 (K063504). Applicant/Manufacturer Information Lite-Med Inc.… | 2001 |
| * | K070665 | Lithoskop | 2008 |
| * | K063504 | Econolith EM1000Summary page 1…as the safety and effectiveness of its predicate devices like Dornier Compact Alpha Lithotripter (K002929), Siemens Lithoskop (KO'70665) and Medispec Econolith EM 1000 (K063504). Applicant/Manufacturer Information Lite-Med Inc. 9th Floor, 49, Dongxing Road, Xinyi District Taipei CityTaiwan,… | 2007 |
What descends from it? (4)
3 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K142561 (Lite-Med, Inc., 2015) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K002929.
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 Lite-Med LM-9200ELMA Lithotripter is indicated for fragmentation of kidney stones such as renal calyx stones and renal pelvic stones and for upper, middle, and lower ureteral stones.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103217: Lite-Med LM-9200 Elma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103217
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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