Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Edap Technomed, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
272 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251910 | Focal One® | Edap Technomed, Inc. | 2025-11-19 | 152 | 0 |
| K172721 | FOCAL ONE | Edap Technomed, Inc. | 2018-06-07 | 272 | 0 |
| K172285 | Ablatherm Fusion | Edap Technomed, Inc. | 2017-10-03 | 67 | 0 |
| K153023 | Ablatherm Integrated Imaging | Edap Technomed, Inc. | 2015-11-06 | 22 | 0 |
| K003529 | SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS | Edap Technomed, Inc. | 2001-02-12 | 88 | 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