Sonio: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Sonio” (first 2023, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 91 days. Since 2017 the median was 91 days, against 102 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 1 | 165 |
| 2024 | 1 | 77 |
| 2025 | 1 | 91 |
| 2026 | 2 | 128 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sonio took a median 91 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 102 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 3 | 3 |
| POK | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | 2 | 2 |
Review panels
- Radiology (5)
Most recent Sonio 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261519 | Sonio Suspect | POK | 2026-06-04 | 28 |
| K252433 | Sonio Detect (v3) | IYN | 2026-03-16 | 227 |
| K243614 | Sonio Suspect | POK | 2025-02-21 | 91 |
| K240406 | Sonio Detect | IYN | 2024-04-26 | 77 |
| K230365 | Sonio Detect | IYN | 2023-07-25 | 165 |
Recalls
openFDA lists no recalls under a recalling firm named Sonio.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Sonio?
FDA lists 5 510(k) clearances under the applicant name “Sonio” (first 2023, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sonio?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sonio is 91 days. Since 2017: 91 days, versus 102 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sonio?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 3); POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer, 2).
Next steps
- See all 5 Sonio clearances with predicates and recalls
- Run predicate analysis for product code IYN, Sonio's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.