Clarius Mobile Health Corp.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Clarius Mobile Health Corp.” (first 2016, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 74 days. Since 2017 the median was 101 days, against 114 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 |
|---|---|---|
| 2016 | 1 | 21 |
| 2017 | 1 | 37 |
| 2018 | 1 | 48 |
| 2019 | 1 | 24 |
| 2020 | 0 | — |
| 2021 | 1 | 24 |
| 2022 | 0 | — |
| 2023 | 3 | 108 |
| 2024 | 1 | 182 |
| 2025 | 2 | 111 |
| 2026 | 1 | 105 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Clarius Mobile Health Corp. took a median 101 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 7 | 7 |
| QIH | Automated Radiological Image Processing Software | 5 | 5 |
Review panels
- Radiology (12)
Most recent Clarius Mobile Health Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253593 | Clarius Ejection Fraction AI | QIH | 2026-03-02 | 105 |
| K250226 | Clarius Median Nerve AI | QIH | 2025-05-08 | 101 |
| K243853 | Clarius Prostate AI | QIH | 2025-04-16 | 121 |
| K233955 | Clarius OB AI | IYN | 2024-06-14 | 182 |
| K232257 | Clarius Bladder AI | QIH | 2023-11-13 | 108 |
| K232704 | Clarius Ultrasound Scanner | IYN | 2023-10-05 | 30 |
| K222406 | Clarius AI | QIH | 2023-01-23 | 167 |
| K213436 | Clarius Ultrasound Scanner | IYN | 2021-11-15 | 24 |
| K192107 | Clarius Ultrasound Scanner | IYN | 2019-08-29 | 24 |
| K180799 | Clarius Ultrasound Scanner | IYN | 2018-05-14 | 48 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Clarius Mobile Health Corp..
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 Clarius Mobile Health Corp.?
FDA lists 12 510(k) clearances under the applicant name “Clarius Mobile Health Corp.” (first 2016, 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 Clarius Mobile Health Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clarius Mobile Health Corp. is 74 days. Since 2017: 101 days, versus 114 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Clarius Mobile Health Corp.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 7); QIH (Automated Radiological Image Processing Software, 5).
Next steps
- See all 12 Clarius Mobile Health Corp. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Clarius Mobile Health Corp.'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.