Edap Technomed, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Edap Technomed, Inc.” (first 2001, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 88 days. Since 2017 the median was 152 days, against 152 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 22 |
| 2016 | 0 | — |
| 2017 | 1 | 67 |
| 2018 | 1 | 272 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 152 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Edap Technomed, Inc. took a median 152 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 152 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PLP | High Intensity Ultrasound System For Prostate Tissue Ablation | 4 | 4 |
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | 1 | 1 |
Review panels
Most recent Edap Technomed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251910 | Focal One® | PLP | 2025-11-19 | 152 |
| K172721 | FOCAL ONE | PLP | 2018-06-07 | 272 |
| K172285 | Ablatherm Fusion | PLP | 2017-10-03 | 67 |
| K153023 | Ablatherm Integrated Imaging | PLP | 2015-11-06 | 22 |
| K003529 | SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS | LNS | 2001-02-12 | 88 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2017-08-14.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Edap Tms France (1 510(k)s)
- Edap International Corp. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Edap Technomed, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Edap Technomed, Inc.” (first 2001, latest 2025), 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 Edap Technomed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Edap Technomed, Inc. is 88 days. Since 2017: 152 days, versus 152 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Edap Technomed, Inc.?
The most frequent FDA product codes under this applicant name are PLP (High Intensity Ultrasound System For Prostate Tissue Ablation, 4); LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological, 1).
Next steps
- See all 5 Edap Technomed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PLP, Edap Technomed, Inc.'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.