510(k) · Cleared

Cleared

LTFS230

K021775510(k) TraditionalCleared Dec 23, 2002208-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

Healthtronics, Inc. · LNS Lithotriptor, Extracorporeal Shock-Wave, Urological

Cleared on Dec 23, 2002 as substantially equivalent to P970019 (Healthtronics Surgical Services, Inc., 1997) after a 208-day review. Its family tree reaches back 1 generation to 1997.

Decided: Dec 23, 2002
Review: 208 days
Class: Class II
Product code: LNS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to P970019 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backP970019 Healthtronics Lithotron Lihtotripsy SystemHealthtronics Surgical Services, Inc. · 1997
This deviceK021775 LTFS230Healthtronics, Inc. · 2002

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)	K021775	LTFS230	Healthtronics, Inc.	2002	—

FIG. 1 — Lineage of K021775, 1997–2002Source: 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 1 …for use in patients with renal imd upper ureteral calculi between 4m and 20mm in size. This device is substantially equivalent to the predicate device, the LithoTron (P970019), also manufactured by HMT. The primary difference in the devicw is that the LithoDiamond has a new imaging system. The equival…	Healthtronics Surgical Services, Inc.	1997	—

Also cleared against P970019: 1 other device →

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?

Its one ancestor has no recall.
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 LithoDiamond is indicated for use in patients with renal and upper ureteral calculi between 4mm and 20mm in size.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021775 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021775: LTFS230.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021775

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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