510(k) · Cleared
ClearedUretron Model Urt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Med-Sonics Corp. · FFK Lithotriptor, Electro-Hydraulic
Cleared on Mar 30, 2012 as substantially equivalent to K102169 (Cybersonics, Inc., 2010) and 2 other predicates after a 347-day review. Its family tree reaches back 5 generations to 1986.
- Decided
- Mar 30, 2012
- Review
- 347 days
- Class
- Class II
- Product code
- FFK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K863642 (1986). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK863642 Candela Model MDL-1 Laser LithotriptorCandela Corp. · 1986
- 4 generations backK963285 Ems Swiss Lithoclast LithotripterElectro Medical Systems SA · 1997
- 3 generations backK012445 Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)Electro Medical Systems SA · 2001 · Recalled
- 2 generations backK052135 Cybersonics Cyberwand Dual Probe LithotripterCybersonics, Inc. · 2005 · Recalled
- 1 generation backK102169 Cyberwand LithotripterCybersonics, Inc. · 2010
- This deviceK111058 Uretron Model UrtMed-Sonics Corp. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K863642 | Candela Model MDL-1 Laser Lithotriptor | Candela Corp. | 1986 | — |
| −4 | K963285 | Ems Swiss Lithoclast Lithotripter | Electro Medical Systems SA | 1997 | — |
| −3 | K012445 | Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra) | Electro Medical Systems SA | 2001 | 3 |
| −2 | K052135 | Cybersonics Cyberwand Dual Probe Lithotripter | Cybersonics, Inc. | 2005 | 1 |
| −1 | K102169 | Cyberwand Lithotripter | Cybersonics, Inc. | 2010 | — |
| 0 (this device) | K111058 | Uretron Model Urt | Med-Sonics Corp. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
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 FFK? 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 FFK device
- #1 K230488 EL27-Compact; Sterile EHL-Probesscore 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K102169 | Cyberwand LithotripterSummary page 1…trasonic lithotripter Classification Name: Lithotripter, Ultrasonic [21 CFR 876.4480] Product Code: FFK Class: 11 PREDICATE DEVICES 510K Number: K102169 Manufacturer: Cybersonics, Inc. Trade Name: CyberWand Hollow Semi-Flexible Ureteral Probe Lithotripter 510K Numbe… | 2010 |
| * | K052135 | Cybersonics Cyberwand Dual Probe LithotripterSummary page 2…obe Lithotripter system issubstantially equivalent to the CyberWand Hollow Semi-Flexible Ureteral Probe Lithotripter (K(102169), the Cyberwand Dual Probe Lithotripter (K052135) and EMS Swiss Lithoclast Master/Ultra (K012445), which were previously cleared for the fragmentation and removal of urinary tra… | 2005 |
| * | K012445 | Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)Summary page 1…exible Ureteral Probe Lithotripter 510K Number: K(052135 Manufacturer: Cybersonics, Inc. Trade Name: CyberWand Dual Probe Lithotripter 510K Number: K012445 Manufacturer: Electro Medical Systems SA. Trade Name: EMS Swiss Lithoclast Master/ Swiss Lithoclast Ultra… | 2001 |
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 26 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K102169.
How does its category compare?
All FFK devicesFFK Lithotriptor, Electro-Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · FFK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FFK
110in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FFK
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FFK
6in 2025
MAUDE reports naming product code FFK, 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 | 2 | — | 1 | 6 |
| 2008 | 0 | — | 0 | 12 |
| 2009 | 0 | — | 1 | 35 |
| 2010 | 2 | — | 0 | 16 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 3 | 110 | 0 | 10 |
| 2014 | 0 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 2 | — | 0 | 7 |
| 2017 | 0 | — | 1 | 9 |
| 2018 | 0 | — | 0 | 18 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 39 |
| 2021 | 1 | — | 1 | 22 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 1 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 2 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The UreTron Multi Probe Lithotripter system is intended to be used for the fragmentation
and removal of urinary tract calculi in the kidney, ureter and bladder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111058 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111058: Uretron Model Urt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111058
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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