510(k) · Cleared

Cleared

Modulth SLK

K120769510(k) SpecialCleared Jun 12, 201290-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

KARL STORZ Endoscopy-America, Inc. · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological

Cleared on Jun 12, 2012 as substantially equivalent to K011700 (Karl Storz Endoscopy, 2002) after a 90-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it.

Decided: Jun 12, 2012
Review: 90 days
Class: Class II
Product code: LNS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011700 (2002). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK011700 Modulith SLK LithotripterKarl Storz Endoscopy · 2002
This deviceK120769 Modulth SLKKARL STORZ Endoscopy-America, Inc. · 2012
Descendant · cites it directly · 0 of its ownK213772 LM-9300 Plus LithotripterLite-Med, Inc. · 2023

Most influential descendants

Showing 1 of 1 · See all

K213772LM-9300 Plus LithotripterLite-Med, Inc. · 2023 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011700	Modulith SLK Lithotripter	Karl Storz Endoscopy	2002	—
0 (this device)	K120769	Modulth SLK	KARL STORZ Endoscopy-America, Inc.	2012	—
+1	K213772	LM-9300 Plus Lithotripter	Lite-Med, Inc.	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2023	1	0

FIG. 1 — Lineage of K120769, 2002–2023Source: 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
*	K011700	Modulith SLK Lithotripter Summary page 1 …ion: 21 CFR 876.5990 Product Code: LNS Predicate Devices: Storz Modulith SLK (K01 1700, cleared 08/16/2002) Indication: The STORZ MEDICAL Lithotripter Model Modulith SLK is…	Karl Storz Endoscopy	2002	—
†	K072788	Storz Modulith Lithotripter SLX-F2-F180	KARL STORZ Endoscopy-America, Inc.	2007	—

Also cleared against K011700: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K213772	LM-9300 Plus Lithotripter	Lite-Med, Inc.	2023	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?

Its one ancestor has no recall.
Of its descendants, K213772 (Lite-Med, Inc., 2023) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K011700.

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. 2012, this device’s year, is highlighted.

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 STORZ MEDICAL Lithotripter Model Modulith SLK is indicated for

use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120769 · printed Nov 5, 2026

Cite this page

510(k) Report. “K120769: Modulth SLK.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120769

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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