510(k) · Cleared
ClearedStone Clear (BWSC-LP9-02)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonomotion, Inc. · QNA Ultrasonic Urinary Stone Propulsion Device
Cleared on Jul 29, 2026 as substantially equivalent to DEN230082 (Sonomotion, Inc., 2024) after a 30-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Jul 29, 2026
- Review
- 30 days
- Class
- Class II
- Product code
- QNA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230082 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backDEN230082 Stone Clear (SC-LP9-01)Sonomotion, Inc. · 2024
- This deviceK262200 Stone Clear (BWSC-LP9-02)Sonomotion, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230082 | Stone Clear (SC-LP9-01) | Sonomotion, Inc. | 2024 | — |
| 0 (this device) | K262200 | Stone Clear (BWSC-LP9-02) | Sonomotion, Inc. | 2026 | — |
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 QNA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 | Decided |
|---|---|---|---|
| * | DEN230082 | Stone Clear (SC-LP9-01)Summary page 5…rology 3. PREDICATE DEVICE The Stone Clear device is substantially equivalent to the previously cleared Stone Clear ultrasonic urinary stone propulsion device (DEN230082, Product Code: QNA). 4. DEVICE DESCRIPTION The Stone Clear device is intended for the repositioning of residual stone fragme… | 2024 |
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.
How does its category compare?
All QNA devicesQNA Ultrasonic Urinary Stone Propulsion Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QNA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QNA
Too few QNA 510(k)s in any year since 2007 to give a median.
Recalls per year · QNA
No recall names QNA since 2007.
Adverse event reports per year · QNA
No MAUDE report names QNA since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Stone Clear ultrasonic propulsion device is indicated for the repositioning of residual stone fragments
post-lithotripsy that are located in the upper urinary tract of adult patients to facilitate passage, where any
individual fragment is less than or equal to 5 mm.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K262200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262200: Stone Clear (BWSC-LP9-02).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262200
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026