510(k) · Cleared

Cleared

Dornier Compact Alpha Lithotripter

K002929510(k) TraditionalCleared Apr 17, 2001209-day reviewClass II21 CFR 876.5990

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dornier Medtech America, Inc. · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological

Cleared on Apr 17, 2001 after a 209-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it.

Decided: Apr 17, 2001
Review: 209 days
Class: Class II
Product code: LNS
Recalls: None
Predicates: 0

24 later devices descend from it, 5 citing it directly.

This deviceK002929 Dornier Compact Alpha LithotripterDornier Medtech America, Inc. · 2001
Descendant · cites it directly · 9 of its ownK040470 Tripter X-1 CompactDirex Systems Corp. · 2004
Descendant · 2 generations on · 8 of its ownK041582 Modification to Tripter X-1 Compact DuetDirex Systems Corp. · 2004
Descendant · cites it directly · 7 of its ownK011773 Dornier Lithotripter 140(Doli 140)Dornier · 2001
Descendant · 2 generations on · 6 of its ownK121656 Gemini LithotripterDornier Medtech America, Inc. · 2012
Descendant · 3 generations on · 6 of its ownK053640 IntegraDirex Systems Corp. · 2006

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2001high 3 (2006) · low 0 (2003)2026

Most influential descendants

Showing 5 of 24 · See all

K040470Tripter X-1 CompactDirex Systems Corp. · 2004 · cites it directly9descendants
K041582Modification to Tripter X-1 Compact DuetDirex Systems Corp. · 2004 · 2 generations on8descendants
K011773Dornier Lithotripter 140(Doli 140)Dornier · 2001 · cites it directly7descendants
K121656Gemini LithotripterDornier Medtech America, Inc. · 2012 · 2 generations on6descendants
K053640IntegraDirex Systems Corp. · 2006 · 3 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002929	Dornier Compact Alpha Lithotripter	Dornier Medtech America, Inc.	2001	—
+1	K040470	Tripter X-1 Compact	Direx Systems Corp.	2004	—
+2	K041582	Modification to Tripter X-1 Compact Duet	Direx Systems Corp.	2004	—
+1	K011773	Dornier Lithotripter 140(Doli 140)	Dornier	2001	—
+2	K121656	Gemini Lithotripter	Dornier Medtech America, Inc.	2012	—
+3	K053640	Integra	Direx Systems Corp.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2004	2	0
2005	1	0
2006	3	0
2008	1	0
2011	1	0
2012	2	0
2013	2	0
2014	2	0
2015	3	0
2021	1	0
2022	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K002929, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (24)

See all 24

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K040470	Tripter X-1 Compact	Direx Systems Corp.	2004	9
K011773	Dornier Lithotripter 140(Doli 140)	Dornier	2001	7
K103217	Lite-Med LM-9200 Elma	Lite-Med, Inc.	2011	4
K142561	LM-9300 ELMA Lithotripter	Lite-Med, Inc.	2015	1
K013471	Delta 2000 Series Extracorporeal Lithotripter	E.S.W.L. Products, Inc.	2002	0

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, K040470 (Direx Systems Corp., 2004) has gone furthest, with 9 descendants of its own.

How does its category compare?

All LNS devices

LNS Lithotriptor, Extracorporeal Shock-Wave, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNS

1in 2025

2007high 4 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNS

111in 2012

2007high 307 (2011) · low 111 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LNS

1in 2015

2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LNS

61in 2025

2007high 86 (2023) · low 2 (2009)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/K002929 · printed Nov 5, 2026

Cite this page

510(k) Report. “K002929: Dornier Compact Alpha Lithotripter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002929

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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