510(k) · Cleared
ClearedDelta 2000 Series Extracorporeal Lithotripter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E.S.W.L. Products, Inc. · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological
Cleared on Apr 29, 2002 as substantially equivalent to K002929 (Dornier Medtech America, Inc., 2001) and 2 other predicates after a 193-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Apr 29, 2002
- Review
- 193 days
- Class
- Class II
- Product code
- LNS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K003529 (2001). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK003529 Sonolith Praktis, Endourology Table PraktisEdap Technomed, Inc. · 2001
- This deviceK013471 Delta 2000 Series Extracorporeal LithotripterE.S.W.L. Products, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003529 | Sonolith Praktis, Endourology Table Praktis | Edap Technomed, Inc. | 2001 | — |
| 0 (this device) | K013471 | Delta 2000 Series Extracorporeal Lithotripter | E.S.W.L. Products, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 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…ification Name/Product Code: 78 LNS Common/Usual Name: Extracorporeal Shock Wave Lithotripter . Equivalent legally marketed devices: Dornier Compact Alpha Lithotripter, K002929; EDAP Technomed Sonolith Praktis, K003529; Storz Modulith Lithotripter Model SLK, K010340. Indications for Use (intended use) Th… | 2001 |
| * | K003529 | Sonolith Praktis, Endourology Table PraktisSummary page 1…/Usual Name: Extracorporeal Shock Wave Lithotripter . Equivalent legally marketed devices: Dornier Compact Alpha Lithotripter, K002929; EDAP Technomed Sonolith Praktis, K003529; Storz Modulith Lithotripter Model SLK, K010340. Indications for Use (intended use) The Delta™ 2000 Series Lithotripter is inten… | 2001 |
| * | K010340 | Modulith Lithotripsy, Model SLK for the Fragmentation of Urinary and Upper Ureteral…Summary page 1…ter . Equivalent legally marketed devices: Dornier Compact Alpha Lithotripter, K002929; EDAP Technomed Sonolith Praktis, K003529; Storz Modulith Lithotripter Model SLK, K010340. Indications for Use (intended use) The Delta™ 2000 Series Lithotripter is intended to fragment urinary stones in the kidney (re… | 2001 |
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?
- None of the 3 ancestors has a recall.
- 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.
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 Delta™ 2000 Series of Extracorporeal Lithotripter is intended to fragment urinary
stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower
ureter).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013471 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013471: Delta 2000 Series Extracorporeal Lithotripter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013471
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026