510(k) · Cleared
ClearedEconolith EM1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medispec, Ltd. · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Cleared on Mar 9, 2007 as substantially equivalent to P870018 (Siemens Corp., 1988) and 2 other predicates after a 109-day review. Its family tree reaches back 2 generations to 1997. 6 later devices descend from it.
- Decided
- Mar 9, 2007
- Review
- 109 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to P970019 (1997). 4 ancestors in all, the oldest P840008 (1984). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backP970019 Healthtronics Lithotron Lihtotripsy SystemHealthtronics Surgical Services, Inc. · 1997
- 1 generation backK040461 Econolith E3000, Model 3000 (SW-6)Medispec, Ltd. · 2004
- This deviceK063504 Econolith EM1000Medispec, Ltd. · 2007
- Descendant · cites it directly · 4 of its ownK103217 Lite-Med LM-9200 ElmaLite-Med, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK142561 LM-9300 ELMA LithotripterLite-Med, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK072788 Storz Modulith Lithotripter SLX-F2-F180KARL STORZ Endoscopy-America, Inc. · 2007
- Descendant · 2 generations on · 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K103217Lite-Med LM-9200 ElmaLite-Med, Inc. · 2011 · cites it directly4descendants
- K142561LM-9300 ELMA LithotripterLite-Med, Inc. · 2015 · 2 generations on1descendant
- K072788Storz Modulith Lithotripter SLX-F2-F180KARL STORZ Endoscopy-America, Inc. · 2007 · cites it directly1descendant
- K242922Extracorporeal Shock Wave Lithotripter (U200)Shenzhen Wikkon Precision Technologies Co., Ltd. · 2025 · 2 generations on0descendants
- K201001Modulith SLX-F2Karl Storz Endoscopy America · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P970019 | Healthtronics Lithotron Lihtotripsy System | Healthtronics Surgical Services, Inc. | 1997 | — |
| −1 | K040461 | Econolith E3000, Model 3000 (SW-6) | Medispec, Ltd. | 2004 | — |
| 0 (this device) | K063504 | Econolith EM1000 | Medispec, Ltd. | 2007 | — |
| +1 | K103217 | Lite-Med LM-9200 Elma | Lite-Med, Inc. | 2011 | — |
| +2 | K142561 | LM-9300 ELMA Lithotripter | Lite-Med, Inc. | 2015 | — |
| +1 | K072788 | Storz Modulith Lithotripter SLX-F2-F180 | KARL STORZ Endoscopy-America, Inc. | 2007 | — |
| +2 | K242922 | Extracorporeal Shock Wave Lithotripter (U200) | Shenzhen Wikkon Precision Technologies Co., Ltd. | 2025 | — |
| +2 | K201001 | Modulith SLX-F2 | Karl Storz Endoscopy America | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | P870018 | LithostarSummary page 2…ry, and * Front Panel Controls Substantial Equivalence The Econolith Tm EM1000 is substantially equivalent to the Seimens Lithostar Lithotripter (approved under PMA# P870018), the Domier Compact Delta (approved under PMA# P8400008/S56), and Medispec Econolith Tm E3000 (cleared under K040461). The EM100… | 1988 |
| * | P840008 | Dornier Lithotripter Compact Transportable (DLCT)Summary page 2…/,it MEDISPEC LTD Predicate Device(s) Siemens Lithostar Lithotripter--870018, Dornier Compact Delta - P840008/S56, and Medispec Econolith TM E3000 - K040461 Device Description Medispec Ltd.'s Econolith Tm EM1000 system is a transportable… | 1984 |
| * | K040461 | Econolith E3000, Model 3000 (SW-6)Summary page 2…MEDISPEC LTD Predicate Device(s) Siemens Lithostar Lithotripter--870018, Dornier Compact Delta - P840008/S56, and Medispec Econolith TM E3000 - K040461 Device Description Medispec Ltd.'s Econolith Tm EM1000 system is a transportable Eectromagmetic4iEM) Extracorporeal Shock Wave… | 2004 |
What descends from it? (6)
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K103217 (Lite-Med, Inc., 2011) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate P870018.
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?
The EM1000 is indicated for use in the non-invasive fragmentation of upper urinary tract stones, to include urinary stones located in the kidney (renal pelvis and renal calyces) and upper ureter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063504 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063504: Econolith EM1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063504
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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