Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Clarius Mobile Health Corp. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
167 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253593 | Clarius Ejection Fraction AI | Clarius Mobile Health Corp. | 2026-03-02 | 105 | 0 |
| K250226 | Clarius Median Nerve AI | Clarius Mobile Health Corp. | 2025-05-08 | 101 | 0 |
| K243853 | Clarius Prostate AI | Clarius Mobile Health Corp. | 2025-04-16 | 121 | 0 |
| K233955 | Clarius OB AI | Clarius Mobile Health Corp. | 2024-06-14 | 182 | 0 |
| K232257 | Clarius Bladder AI | Clarius Mobile Health Corp. | 2023-11-13 | 108 | 0 |
| K232704 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | 2023-10-05 | 30 | 0 |
| K222406 | Clarius AI | Clarius Mobile Health Corp. | 2023-01-23 | 167 | 0 |
| K213436 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | 2021-11-15 | 24 | 0 |
| K192107 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | 2019-08-29 | 24 | 0 |
| K180799 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp. | 2018-05-14 | 48 | 0 |
| K172385 | Clarius Ultrasound System | Clarius Mobile Health Corp. | 2017-09-14 | 37 | 0 |
| K163138 | Clarius Ultrasound System | Clarius Mobile Health Corp. | 2016-11-30 | 21 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda