510(k) · Cleared
ClearedExtracorporeal Shock Wave Lithotripter, Comed Asadal-M1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Comed Medical Systems Co., Ltd. · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Cleared on Jul 22, 2014 as substantially equivalent to K101482 (Elite Medical, Inc., 2011) and 1 other predicate after a 405-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Jul 22, 2014
- Review
- 405 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to P970019 (1997). 11 ancestors in all, the oldest P840008 (1984). No later device cites it as a predicate yet.
- Root · 4 generations backP970019 Healthtronics Lithotron Lihtotripsy SystemHealthtronics Surgical Services, Inc. · 1997
- 3 generations backK040461 Econolith E3000, Model 3000 (SW-6)Medispec, Ltd. · 2004
- 2 generations backK063504 Econolith EM1000Medispec, Ltd. · 2007
- 1 generation backK103217 Lite-Med LM-9200 ElmaLite-Med, Inc. · 2011
- This deviceK131721 Extracorporeal Shock Wave Lithotripter, Comed Asadal-M1Comed Medical Systems Co., Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P970019 | Healthtronics Lithotron Lihtotripsy System | Healthtronics Surgical Services, Inc. | 1997 | — |
| −3 | K040461 | Econolith E3000, Model 3000 (SW-6) | Medispec, Ltd. | 2004 | — |
| −2 | K063504 | Econolith EM1000 | Medispec, Ltd. | 2007 | — |
| −1 | K103217 | Lite-Med LM-9200 Elma | Lite-Med, Inc. | 2011 | — |
| 0 (this device) | 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 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 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? (2)
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 |
|---|---|---|---|
| * | K101482 | EM-9000Summary page 1…LNS Device Class: 11 3. Predicate Devices: Primary Predicate device is the EM-9000 [K101482], Elite Medical Inc., Atlanta, GA. The associate Predicate device is the Lite-Med LM-9200 EOLMA,… | 2011 |
| * | K103217 | Lite-Med LM-9200 ElmaSummary page 1…te device is the EM-9000 [K101482], Elite Medical Inc., Atlanta, GA. The associate Predicate device is the Lite-Med LM-9200 EOLMA, [K1 03217], Lite-Med, Inc., and Taipei City, Taiwan. 4. Indications: The GEMSS UROCAMP ASADAL-Mi, Extracor… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 1 other device also cites its predicate K101482.
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. 2014, 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 GEMISS UROCAMP ASADAL-MI 1, Extracorporeal Shockwave Lithotripler 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/K131721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131721: Extracorporeal Shock Wave Lithotripter, Comed Asadal-M1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131721
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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