510(k) · Cleared
Recalled · Class II · 2018Lma Stonebreaker Device; Probe Size 1.0MM, 1.6MM, 2.0MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Laryngeal Mask Co., Ltd. · FFK Lithotriptor, Electro-Hydraulic
Cleared on May 9, 2007 as substantially equivalent to K951531 (Electro Medical Systems SA, 1995) and 2 other predicates after a 258-day review. Its family tree reaches back 3 generations to 1986. 1 later device descends from it. It has been recalled 7 times.
- Decided
- May 9, 2007
- Review
- 258 days
- Class
- Class II
- Product code
- FFK
- Recalls
- 7
- Predicates
- 3
Its longest line of descent runs back 3 generations to K863642 (1986). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK863642 Candela Model MDL-1 Laser LithotriptorCandela Corp. · 1986
- 2 generations backK963285 Ems Swiss Lithoclast LithotripterElectro Medical Systems SA · 1997
- 1 generation backK974164 Swiss Lithoclast Master Handpiece and 3.2 MM ProbeMedical Device Consultants, Inc. · 1997
- This deviceK062475 Lma Stonebreaker Device; Probe Size 1.0MM, 1.6MM, 2.0MMThe Laryngeal Mask Co., Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK123038 Swiss LithobreakerE.M.S Electro Medical Systems S.A · 2013
Most influential descendants
Showing 1 of 1 · See all- K123038Swiss LithobreakerE.M.S Electro Medical Systems S.A · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K863642 | Candela Model MDL-1 Laser Lithotriptor | Candela Corp. | 1986 | — |
| −2 | K963285 | Ems Swiss Lithoclast Lithotripter | Electro Medical Systems SA | 1997 | — |
| −1 | K974164 | Swiss Lithoclast Master Handpiece and 3.2 MM Probe | Medical Device Consultants, Inc. | 1997 | — |
| 0 (this device) | K062475 | Lma Stonebreaker Device; Probe Size 1.0MM, 1.6MM, 2.0MM | The Laryngeal Mask Co., Ltd. | 2007 | — |
| +1 | K123038 | Swiss Lithobreaker | E.M.S Electro Medical Systems S.A | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K951531 | Swiss Lithoclast LithotripterSummary page 2…Predicate 1: Swiss LithoClast® (for fragmentation of ureteral and bladder stones) already marketed in the USA under K951531 Predicate 2: Swiss LithoClast® (for fragmentation Of ureteral, bladder and kidney stones… | 1995 |
| * | K963285 | Ems Swiss Lithoclast LithotripterSummary page 2…e 2: Swiss LithoClast® (for fragmentation Of ureteral, bladder and kidney stones) already marketed in the USA under K963285 Predicate 3: Swiss LithoClast®~Master already marketed in the USA under K974164 3.… | 1997 |
| * | K974164 | Swiss Lithoclast Master Handpiece and 3.2 MM ProbeSummary page 2…eted in the USA under K963285 Predicate 3: Swiss LithoClast®~Master already marketed in the USA under K974164 3. Device Description The LNA.A Stone~AreakerTMV isAporrtable nnn-eiectricAl, pneuimatfic contnc~t intracorpor… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123038 | Swiss Lithobreaker | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 31, 2018 | Class II | Z-1593-2018 | Error in labeling | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use. |
| Jan 31, 2018 | Class II | Z-1592-2018 | Error in labeling | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use. |
| Jan 31, 2018 | Class II | Z-1594-2018 | Error in labeling | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use. |
| Jan 31, 2018 | Class II | Z-1595-2018 | Error in labeling | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use. |
| Jan 31, 2018 | Class II | Z-1596-2018 | Error in labeling | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use. |
| Jan 31, 2018 | Class II | Z-1590-2018 | Error in labeling | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use. |
| Jan 31, 2018 | Class II | Z-1591-2018 | Error in labeling | The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 9.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K123038 (E.M.S Electro Medical Systems S.A, 2013) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K951531.
How does its category compare?
All FFK devicesFFK Lithotriptor, Electro-Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 LMA StoneBreakerTM is indicated for use via a rigid or semi-rigid endoscope with a straight working channel, for the fragmentation of urinary tract (i.e. kidney, ureter and bladder) stones.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062475 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062475: Lma Stonebreaker Device; Probe Size 1.0MM, 1.6MM, 2.0MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062475
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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