PMA · Approved
ApprovedHealthtronics Lithotron Lihtotripsy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthtronics Surgical Services, Inc. · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Approved on Jul 21, 1997 through premarket approval, which rests on the device’s own clinical evidence after a 66-day review. 9 later devices descend from it.
- Decided
- Jul 21, 1997
- Review
- 66 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
9 later devices descend from it, 2 citing it directly.
- This deviceP970019 Healthtronics Lithotron Lihtotripsy SystemHealthtronics Surgical Services, Inc. · 1997
- Descendant · cites it directly · 7 of its ownK040461 Econolith E3000, Model 3000 (SW-6)Medispec, Ltd. · 2004
- Descendant · 2 generations on · 6 of its ownK063504 Econolith EM1000Medispec, Ltd. · 2007
- Descendant · 3 generations on · 4 of its ownK103217 Lite-Med LM-9200 ElmaLite-Med, Inc. · 2011
- Descendant · 4 generations on · 1 of its ownK142561 LM-9300 ELMA LithotripterLite-Med, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK072788 Storz Modulith Lithotripter SLX-F2-F180KARL STORZ Endoscopy-America, Inc. · 2007
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K040461Econolith E3000, Model 3000 (SW-6)Medispec, Ltd. · 2004 · cites it directly7descendants
- K063504Econolith EM1000Medispec, Ltd. · 2007 · 2 generations on6descendants
- K103217Lite-Med LM-9200 ElmaLite-Med, Inc. · 2011 · 3 generations on4descendants
- K142561LM-9300 ELMA LithotripterLite-Med, Inc. · 2015 · 4 generations on1descendant
- K072788Storz Modulith Lithotripter SLX-F2-F180KARL STORZ Endoscopy-America, Inc. · 2007 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P970019 | Healthtronics Lithotron Lihtotripsy System | Healthtronics Surgical Services, Inc. | 1997 | — |
| +1 | K040461 | Econolith E3000, Model 3000 (SW-6) | Medispec, Ltd. | 2004 | — |
| +2 | K063504 | Econolith EM1000 | Medispec, Ltd. | 2007 | — |
| +3 | K103217 | Lite-Med LM-9200 Elma | Lite-Med, Inc. | 2011 | — |
| +4 | K142561 | LM-9300 ELMA Lithotripter | Lite-Med, Inc. | 2015 | — |
| +3 | K072788 | Storz Modulith Lithotripter SLX-F2-F180 | KARL STORZ Endoscopy-America, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA PMA database (decision fields and supplements), 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (9)
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?
- Of its descendants, K040461 (Medispec, Ltd., 2004) has gone furthest, with 7 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.
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 | — |
https://510kreport.com/device/P970019 · printed Nov 4, 2026
Cite this page
510(k) Report. “P970019: Healthtronics Lithotron Lihtotripsy System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P970019
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026