Sonomotion, Inc.: FDA clearances and approvals
Sonomotion, Inc. has 3 FDA 510(k) clearances (first 2026, latest 2026), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time: 30 days. Since 2017 its median was 30 days, against 150 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2026 | 3 | 30 |
Review time against the same product codes
Since 2017, Sonomotion, Inc.'s cleared 510(k)s took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 150 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | 2 | 2 |
| QNA | Ultrasonic Urinary Stone Propulsion Device | 2 | 1 |
Review panels
Most recent Sonomotion, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262200 | Stone Clear (BWSC-LP9-02) | QNA | 2026-07-29 | 30 |
| K261086 | Break Wave | LNS | 2026-04-29 | 28 |
| K252913 | Break Wave | LNS | 2026-01-12 | 122 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230082 | De Novo | Ultrasonic Urinary Stone Propulsion Device | 2024-10-30 |
Recalls
openFDA lists no recalls under a recalling firm named Sonomotion, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Sonomotion, Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05701098: SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD) (Completed, started 2023-10-09)
- NCT03811171: Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study (Recruiting, started 2019-08-20)
Frequently asked questions
How many FDA 510(k) clearances does Sonomotion, Inc. have?
Sonomotion, Inc. has 3 FDA 510(k) clearances (first 2026, latest 2026), plus 1 De Novo decision, across 2 product codes in 1 review panel.
How long does FDA take to clear Sonomotion, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Sonomotion, Inc.'s cleared 510(k)s is 30 days. Since 2017: 30 days, versus 150 days for all cleared 510(k)s in the same product codes.
What devices does Sonomotion, Inc. make?
Its most frequent FDA product codes are LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological, 2); QNA (Ultrasonic Urinary Stone Propulsion Device, 2).
Has Sonomotion, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sonomotion, Inc. Related entities may recall under other names.
Next steps
- See all 3 Sonomotion, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNS, Sonomotion, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.