510(k) Report

510(k) · Cleared

Cleared

Duet Magna

K111947510(k) TraditionalCleared Mar 1, 2012237-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

Direx Systems Corp. · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological

Cleared on Mar 1, 2012 as substantially equivalent to K023535 (Direx Systems Corp., 2003) and 2 other predicates after a 237-day review. Its family tree reaches back 5 generations to 1984.

Decided
Mar 1, 2012
Review
237 days
Class
Class II
Product code
LNS
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to P840008 (1984). 16 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestor2004: 1 other ancestor2002: 1 other ancestor2001: 2 other ancestors1996: 1 other ancestor1995: 1 other ancestor1997: 2 other ancestors1989: 1 other ancestor1988: 1 other ancestorP840008 · 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. · 20061980198519901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 5 other ancestors3 generations back: 4 other ancestors4 generations back: 1 other ancestor K053640 · 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 · 5 generations backP840008 Dornier Lithotripter Compact Transportable (DLCT)Dornier Medtech America, Inc. · 1984
  2. 4 generations backK011873 Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli…Dornier · 2001
  3. 3 generations backK040470 Tripter X-1 CompactDirex Systems Corp. · 2004
  4. 2 generations backK041582 Modification to Tripter X-1 Compact DuetDirex Systems Corp. · 2004
  5. 1 generation backK053640 IntegraDirex Systems Corp. · 2006
  6. This deviceK111947 Duet MagnaDirex Systems Corp. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5P840008Dornier Lithotripter Compact Transportable (DLCT)Dornier Medtech America, Inc.1984—
−4K011873Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli S-XP)Dornier2001—
−3K040470Tripter X-1 CompactDirex Systems Corp.2004—
−2K041582Modification to Tripter X-1 Compact DuetDirex Systems Corp.2004—
−1K053640IntegraDirex Systems Corp.2006—
0 (this device)K111947Duet MagnaDirex Systems Corp.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
198910
199510
199610
199720
200120
200210
200310
200410
FIG. 1 — Lineage of K111947, 1984–2012Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K023535Tripter X-1 Compact Duet
Summary page 1
…code: 78 LNS Panel: Gastroenterology and Urology 3. Predicate Devices Tripter X - 1 Compact Duet (Direx Systems Corp) ( K023535) Tripter X- 1 Compact Duet (Direx Systems Corp) (K041582) Integra (Direx Systems Corp) K053640) 4.…
Direx Systems Corp.2003—
*K041582Modification to Tripter X-1 Compact Duet
Summary page 1
…Gastroenterology and Urology 3. Predicate Devices Tripter X - 1 Compact Duet (Direx Systems Corp) ( K023535) Tripter X- 1 Compact Duet (Direx Systems Corp) (K041582) Integra (Direx Systems Corp) K053640) 4. Intended Use: The DUET MAGNA is intended to fragment uri…
Direx Systems Corp.2004—
*K053640Integra
Summary page 1
…ripter X - 1 Compact Duet (Direx Systems Corp) ( K023535) Tripter X- 1 Compact Duet (Direx Systems Corp) (K041582) Integra (Direx Systems Corp) K053640) 4. Intended Use: The DUET MAGNA is intended to fragment urinary stones inthe kidney (renal pelvis and renal calyces)…
Direx Systems Corp.2006—

Also cleared against K023535: 3 other devices →

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?

  • The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
  • None of the 16 ancestors has a recall.
  • 3 other devices also cite its predicate K023535.

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

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?

DUET MAGNA is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter.

Indications for use as stated in the FDA summary.

Also cleared against K023535

3 other devices cite the same predicate.

  • K050091Tripter-X1 Compact Duet SP (Separated Pulse)Direx Systems Corp. · 2005
  • K041582Modification to Tripter X-1 Compact DuetDirex Systems Corp. · 2004
  • K040470Tripter X-1 CompactDirex Systems Corp. · 2004

More from Direx Systems Corp.

22 FDA decisions under this applicant name. See the company

  • K102765PronexDirex Systems Corp. · 2010
  • K072529TrackportDirex Systems Corp. · 2007
  • K071701Trackleaf-10Direx Systems Corp. · 2007
  • K063482Crossplan / Accusoft-XL V.4.04Direx Systems Corp. · 2006
  • K062147Integra SLDirex Systems Corp. · 2006

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/K111947 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111947: Duet Magna.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111947

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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