510(k) · Cleared

Cleared

Tripter-X1 Compact Duet SP (Separated Pulse)

K050091510(k) SpecialCleared Mar 16, 200561-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 16, 2005 as substantially equivalent to K023535 (Direx Systems Corp., 2003) and 2 other predicates after a 61-day review. Its family tree reaches back 4 generations to 1984.

Decided: Mar 16, 2005
Review: 61 days
Class: Class II
Product code: LNS
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to P840008 (1984). 15 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backP840008 Dornier Lithotripter Compact Transportable (DLCT)Dornier Medtech America, Inc. · 1984
3 generations backK011873 Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli…Dornier · 2001
2 generations backK040470 Tripter X-1 CompactDirex Systems Corp. · 2004
1 generation backK041582 Modification to Tripter X-1 Compact DuetDirex Systems Corp. · 2004
This deviceK050091 Tripter-X1 Compact Duet SP (Separated Pulse)Direx Systems Corp. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	P840008	Dornier Lithotripter Compact Transportable (DLCT)	Dornier Medtech America, Inc.	1984	—
−3	K011873	Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli S-XP)	Dornier	2001	—
−2	K040470	Tripter X-1 Compact	Direx Systems Corp.	2004	—
−1	K041582	Modification to Tripter X-1 Compact Duet	Direx Systems Corp.	2004	—
0 (this device)	K050091	Tripter-X1 Compact Duet SP (Separated Pulse)	Direx Systems Corp.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1989	1	0
1995	1	0
1996	1	0
1997	1	0
2001	3	0
2002	1	0
2003	2	0

FIG. 1 — Lineage of K050091, 1984–2005Source: 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K023535	Tripter X-1 Compact Duet Summary page 1 …tion Name/ Product code: 78 LNS Regulatory Class: Class 11 Regulation Number: 21 CFR 876.5990 3. Predicate Devices Duet k023535, Duet SLO k041582, and TWINHEADS TH-101 k030346 6-1 4. Intended Use: T…	Direx Systems Corp.	2003	—
*	K041582	Modification to Tripter X-1 Compact Duet Summary page 1 …code: 78 LNS Regulatory Class: Class 11 Regulation Number: 21 CFR 876.5990 3. Predicate Devices Duet k023535, Duet SLO k041582, and TWINHEADS TH-101 k030346 6-1 4. Intended Use: The intended use of…	Direx Systems Corp.	2004	—
*	K030346	Twinheads TH-101 Extracorporeal Shock Wave Lithotripter Summary page 1 …lass: Class 11 Regulation Number: 21 CFR 876.5990 3. Predicate Devices Duet k023535, Duet SLO k041582, and TWINHEADS TH-101 k030346 6-1 4. Intended Use: The intended use of the Duet SP Extracorporeal Sh…	Fmd, LLC	2003	—

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 21 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
None of the 15 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.

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 intended use of the Duet SP Extracorporeal Shock Wave Lithotripter is the fragmentation of urinary tract stones (i.e. renal calyceal, renal pevic, and upper ureteral stones).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050091 · printed Nov 5, 2026

Cite this page

510(k) Report. “K050091: Tripter-X1 Compact Duet SP (Separated Pulse).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050091

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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