Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sofwave Medical, Ltd. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
122 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251746 | Pure Impact | Sofwave Medical, Ltd. | 2025-07-02 | 26 | 0 |
| K250146 | SofWave System | Sofwave Medical, Ltd. | 2025-04-18 | 87 | 0 |
| K241685 | SofWave System | Sofwave Medical, Ltd. | 2024-08-07 | 57 | 0 |
| K240687 | SofWave System | Sofwave Medical, Ltd. | 2024-05-30 | 79 | 0 |
| K233104 | SofWave System | Sofwave Medical, Ltd. | 2023-12-22 | 87 | 0 |
| K232455 | SofWave System | Sofwave Medical, Ltd. | 2023-12-14 | 122 | 0 |
| K231537 | SofWave System | Sofwave Medical, Ltd. | 2023-08-28 | 90 | 0 |
| K230820 | SofWave System | Sofwave Medical, Ltd. | 2023-04-18 | 25 | 0 |
| K230019 | SofWave System | Sofwave Medical, Ltd. | 2023-03-14 | 70 | 0 |
| K223237 | SofWave System | Sofwave Medical, Ltd. | 2022-12-16 | 58 | 0 |
| K211483 | SofWave System | Sofwave Medical, Ltd. | 2021-11-15 | 187 | 0 |
| K191421 | Sofacia System | Sofwave Medical, Ltd. | 2019-09-09 | 104 | 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