510(k) · Cleared

Cleared

Econolith E3000, Model 3000 (SW-6)

K040461510(k) SpecialCleared May 25, 200492-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

Medispec, Ltd. · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological

Cleared on May 25, 2004 as substantially equivalent to P970019 (Healthtronics Surgical Services, Inc., 1997) after a 92-day review. Its family tree reaches back 1 generation to 1997. 7 later devices descend from it.

Decided: May 25, 2004
Review: 92 days
Class: Class II
Product code: LNS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to P970019 (1997). 7 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backP970019 Healthtronics Lithotron Lihtotripsy SystemHealthtronics Surgical Services, Inc. · 1997
This deviceK040461 Econolith E3000, Model 3000 (SW-6)Medispec, Ltd. · 2004
Descendant · cites it directly · 6 of its ownK063504 Econolith EM1000Medispec, Ltd. · 2007
Descendant · 2 generations on · 4 of its ownK103217 Lite-Med LM-9200 ElmaLite-Med, Inc. · 2011
Descendant · 3 generations on · 1 of its ownK142561 LM-9300 ELMA LithotripterLite-Med, Inc. · 2015
Descendant · 2 generations on · 1 of its ownK072788 Storz Modulith Lithotripter SLX-F2-F180KARL STORZ Endoscopy-America, Inc. · 2007
Descendant · 3 generations on · 0 of its ownK242922 Extracorporeal Shock Wave Lithotripter (U200)Shenzhen Wikkon Precision Technologies Co., Ltd. · 2025

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2007high 2 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 7 · See all

K063504Econolith EM1000Medispec, Ltd. · 2007 · cites it directly6descendants
K103217Lite-Med LM-9200 ElmaLite-Med, Inc. · 2011 · 2 generations on4descendants
K142561LM-9300 ELMA LithotripterLite-Med, Inc. · 2015 · 3 generations on1descendant
K072788Storz Modulith Lithotripter SLX-F2-F180KARL STORZ Endoscopy-America, Inc. · 2007 · 2 generations on1descendant
K242922Extracorporeal Shock Wave Lithotripter (U200)Shenzhen Wikkon Precision Technologies Co., Ltd. · 2025 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	P970019	Healthtronics Lithotron Lihtotripsy System	Healthtronics Surgical Services, Inc.	1997	—
0 (this device)	K040461	Econolith E3000, Model 3000 (SW-6)	Medispec, Ltd.	2004	—
+1	K063504	Econolith EM1000	Medispec, Ltd.	2007	—
+2	K103217	Lite-Med LM-9200 Elma	Lite-Med, Inc.	2011	—
+3	K142561	LM-9300 ELMA Lithotripter	Lite-Med, Inc.	2015	—
+2	K072788	Storz Modulith Lithotripter SLX-F2-F180	KARL STORZ Endoscopy-America, Inc.	2007	—
+3	K242922	Extracorporeal Shock Wave Lithotripter (U200)	Shenzhen Wikkon Precision Technologies Co., Ltd.	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2011	1	0
2014	1	0
2015	1	0
2021	1	0
2025	1	0

FIG. 1 — Lineage of K040461, 1997–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	P970019	Healthtronics Lithotron Lihtotripsy System Summary page 2 …/,f,'r~~~~~~~~~~~~~~~~~~~~~~~~~~1 MEDISPEC LTD Predicate Device Health~ronic's Litholron Lithotripsy System (P970019) Device Description Medispec Ltd.'s EconolithTM E3000 uses shock waves generated outside the patient's body to fragment urinary…	Healthtronics Surgical Services, Inc.	1997	—

Also cleared against P970019: 1 other device →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K063504	Econolith EM1000	Medispec, Ltd.	2007	6

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?

Its one ancestor has no recall.
Of its descendants, K063504 (Medispec, Ltd., 2007) has gone furthest, with 6 descendants of its own.
1 other device also cites its predicate P970019.

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	—

What is it indicated for?

The EconolithTM E3000 is indicated for use in non-invasive fragmentation of upper urinary tract stones between 5 and 20 mm in size.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040461 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040461: Econolith E3000, Model 3000 (SW-6).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040461

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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