510(k) Report

510(k) · Cleared

Cleared

Piezolith 3000 Triple-Focus Lithotripter

K072538510(k) TraditionalCleared Jan 30, 2008145-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

United Medical Systems, Inc. · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological

Cleared on Jan 30, 2008 as substantially equivalent to K032958 (United Medical Systems, Inc., 2004) and 5 other predicates after a 145-day review. Its family tree reaches back 6 generations to 1984. 2 later devices descend from it.

Decided
Jan 30, 2008
Review
145 days
Class
Class II
Product code
LNS
Recalls
None
Predicates
6

Its longest line of descent runs back 6 generations to P840008 (1984). 20 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 2 other ancestors2002: 2 other ancestors2001: 3 other ancestors1995: 1 other ancestor2003: 1 other ancestor1997: 2 other ancestors1996: 1 other ancestor1989: 1 other ancestor1988: 1 other ancestor2026: 2 descendants clearedP840008 · Dornier Lithotripter Compact Transportable (DLCT) · Dornier Medtech America, Inc. · 1984K011873 · Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli S-XP) · Dornier · 2001×2: 2 generations cleared close together, K040470 (2004), K041582 (2004) K053640 · Integra · Direx Systems Corp. · 2006K062147 · Integra SL · Direx Systems Corp. · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 2 other ancestors3 generations back: 2 other ancestors4 generations back: 5 other ancestors5 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant K062147 · Integra SL · Direx Systems Corp. · 2006K053640 · Integra · Direx Systems Corp. · 2006K041582 · Modification to Tripter X-1 Compact Duet · Direx Systems Corp. · 2004K040470 · Tripter X-1 Compact · Direx Systems Corp. · 2004K011873 · Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli S-XP) · Dornier · 2001P840008 · Dornier Lithotripter Compact Transportable (DLCT) · Dornier Medtech America, Inc. · 1984−50
  1. Root · 6 generations backP840008 Dornier Lithotripter Compact Transportable (DLCT)Dornier Medtech America, Inc. · 1984
  2. 5 generations backK011873 Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli…Dornier · 2001
  3. 4 generations backK040470 Tripter X-1 CompactDirex Systems Corp. · 2004
  4. 3 generations backK041582 Modification to Tripter X-1 Compact DuetDirex Systems Corp. · 2004
  5. 2 generations backK053640 IntegraDirex Systems Corp. · 2006
  6. 1 generation backK062147 Integra SLDirex Systems Corp. · 2006
  7. This deviceK072538 Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc. · 2008
  8. Descendant · cites it directly · 1 of its ownK252913 Break WaveSonomotion, Inc. · 2026
  9. Descendant · 2 generations on · 0 of its ownK261086 Break WaveSonomotion, Inc. · 2026

Most influential descendants

Showing 2 of 2 · See all
  • K252913Break WaveSonomotion, Inc. · 2026 · cites it directly1descendant
  • K261086Break WaveSonomotion, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6P840008Dornier Lithotripter Compact Transportable (DLCT)Dornier Medtech America, Inc.1984—
−5K011873Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli S-XP)Dornier2001—
−4K040470Tripter X-1 CompactDirex Systems Corp.2004—
−3K041582Modification to Tripter X-1 Compact DuetDirex Systems Corp.2004—
−2K053640IntegraDirex Systems Corp.2006—
−1K062147Integra SLDirex Systems Corp.2006—
0 (this device)K072538Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc.2008—
+1K252913Break WaveSonomotion, Inc.2026—
+2K261086Break WaveSonomotion, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
198910
199510
199610
199720
200130
200220
200310
200420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202620
FIG. 1 — Lineage of K072538, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252913 Break Wavescore 15.5 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K032958Piezolith 3000 Lithotripter, Model 3000
Summary page 1
…e Extracorporeal Shock Wave Lithotripsy System/ Urological Lithotripter Predicate Devices United Medical Systems (DE), Inc.'s Piezolith 3000 Lithotripter (K032958) Karl Storz Modulith Lithotripter (K010340, K012482, K011700) Direx Systems Corporation Integra (K053640, K062147) I…
United Medical Systems, Inc.2004—
*K010340Modulith Lithotripsy, Model SLK for the Fragmentation of Urinary and Upper Ureteral…
Summary page 1
…stem/ Urological Lithotripter Predicate Devices United Medical Systems (DE), Inc.'s Piezolith 3000 Lithotripter (K032958) Karl Storz Modulith Lithotripter (K010340, K012482, K011700) Direx Systems Corporation Integra (K053640, K062147) Intended Use / Indications for Use The Piez…
Karl Storz Lithotripsy-America, Inc.2001—
*K012482Storz Modulith SLK Lithotripter with Multiview Option
Summary page 1
…logical Lithotripter Predicate Devices United Medical Systems (DE), Inc.'s Piezolith 3000 Lithotripter (K032958) Karl Storz Modulith Lithotripter (K010340, K012482, K011700) Direx Systems Corporation Integra (K053640, K062147) Intended Use / Indications for Use The Piezolith 300…
KARL STORZ Endoscopy-America, Inc.2001—
*K011700Modulith SLK Lithotripter
Summary page 1
…ithotripter Predicate Devices United Medical Systems (DE), Inc.'s Piezolith 3000 Lithotripter (K032958) Karl Storz Modulith Lithotripter (K010340, K012482, K011700) Direx Systems Corporation Integra (K053640, K062147) Intended Use / Indications for Use The Piezolith 3000 Triple-…
Karl Storz Endoscopy2002—
*K053640Integra
Summary page 1
…al Systems (DE), Inc.'s Piezolith 3000 Lithotripter (K032958) Karl Storz Modulith Lithotripter (K010340, K012482, K011700) Direx Systems Corporation Integra (K053640, K062147) Intended Use / Indications for Use The Piezolith 3000 Triple-Focus is intended to fragment urinary stones in th…
Direx Systems Corp.2006—
*K062147Integra SL
Summary page 1
…s (DE), Inc.'s Piezolith 3000 Lithotripter (K032958) Karl Storz Modulith Lithotripter (K010340, K012482, K011700) Direx Systems Corporation Integra (K053640, K062147) Intended Use / Indications for Use The Piezolith 3000 Triple-Focus is intended to fragment urinary stones in the k…
Direx Systems Corp.2006—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K252913Break WaveSonomotion, Inc.20261

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 24 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
  • None of the 20 ancestors has a recall.
  • Of its descendants, K252913 (Sonomotion, Inc., 2026) has gone furthest, with 1 descendant 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. 2008, this device’s year, is highlighted.

FDA decisions per year · LNS

1in 2025

2007: 42008: 22009: 12011: 32012: 32013: 22014: 22015: 22017: 22020: 12021: 12023: 22025: 12026 (partial year): 2
2007high 4 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNS

111in 2012

2007: 146 days median2011: 307 days median2012: 111 days median
2007high 307 (2011) · low 111 (2012)2026

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

Recalls per year · LNS

1in 2015

2015: 1
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

2007: 42008: 102009: 22010: 152011: 212012: 202013: 182014: 212015: 222016: 502017: 542018: 592019: 602020: 382021: 552022: 522023: 862024: 402025: 61
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007414604
20082—010
20091—02
20100—015
20113307021
20123111020
20132—018
20142—021
20152—122
20160—050
20172—054
20180—059
20190—060
20201—038
20211—055
20220—052
20232—086
20240—040
20251—061
20262—0—

What is it indicated for?

The Piezolith 3000 Triple-Focus is intended to fragment urinary stones in the

kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

Indications for use as stated in the FDA summary.

More from United Medical Systems, Inc.

5 FDA decisions under this applicant name. See the company

  • K032958Piezolith 3000 Lithotripter, Model 3000United Medical Systems, Inc. · 2004
  • K894949SQAUnited Medical Systems, Inc. · 1989
  • K893003Tocolytic Site Care Sup Kit #1001/100A/Carry CaseUnited Medical Systems, Inc. · 1989
  • K863645Schulman Double Umbilical Cord Clamp NO. 1000United Medical Systems, Inc. · 1986

Recent decisions in LNS

The LNS category page

  • K261086Break WaveSonomotion, Inc. · 2026
  • K252913Break WaveSonomotion, Inc. · 2026
  • K242922Extracorporeal Shock Wave Lithotripter (U200)Shenzhen Wikkon Precision Technologies Co., Ltd. · 2025
  • K221903Delta III ProDornier Medtech America, Inc. · 2023
  • K213772LM-9300 Plus LithotripterLite-Med, Inc. · 2023

https://510kreport.com/device/K072538 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072538: Piezolith 3000 Triple-Focus Lithotripter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072538

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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