Break Wave
FDA 510(k) clearance K252913 · decided 2026-01-12
Clearance details
- K-number
- K252913
- Device name
- Break Wave
- Applicant
- Sonomotion, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-12
- Decision date
- 2026-01-12
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- LNS
- Device class
- 2
- Regulation number
- 876.5990
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Mateo, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Break Wave (K261086) | Sonomotion, Inc. | 2026-04-29 |
| Extracorporeal Shock Wave Lithotripter (U200) (K242922) | Shenzhen Wikkon Precision Technologies Co., Ltd. | 2025-06-18 |
| Delta III Pro (K221903) | Dornier Medtech America, Inc. | 2023-02-22 |
| LM-9300 Plus Lithotripter (K213772) | Lite-Med, Inc. | 2023-01-19 |
| Modulith SLX-F2 (K201001) | Karl Storz Endoscopy America | 2021-03-30 |
| Delta III Lithotripter (K201074) | Dornier Medtech America, Inc. | 2020-09-03 |
| Delta III Lithotripter (K172084) | Dornier Medtech America, Inc. | 2017-08-08 |
| Delta III Lithotripter (K170122) | Dornier Medtech America | 2017-06-28 |
| Gemini XXP-HP (K151298) | Dornier Medtech America | 2015-07-30 |
| LM-9300 ELMA Lithotripter (K142561) | Lite-Med, Inc. | 2015-03-20 |
| EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER (K131817) | Osmunda Medical Device Consulting Co., Ltd. | 2014-09-26 |
| EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1 (K131721) | Comed Medical Systems Co., Ltd. | 2014-07-22 |
Recalls involving this device
No recalls on record reference this clearance.