Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HistoSonics, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252947 | HistoSonicsĀ® Planning Tool | HistoSonics, Inc. | 2026-05-29 | 256 | 0 |
| K241902 | Edison System | HistoSonics, Inc. | 2024-10-30 | 121 | 0 |
| K233466 | Edison System | HistoSonics, Inc. | 2024-03-13 | 141 | 0 |
| DEN220087 | Edison System | HistoSonics, Inc. | 2023-10-06 | 308 | 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