Tecnimed S.R.L.: FDA filings under this applicant name
FDA lists 4 510(k) clearances under the applicant name “Tecnimed S.R.L.” (first 2004, latest 2017), plus 1 De Novo decision, across 2 product codes in 2 review panels. Median 510(k) review time under this name: 200 days. 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 | 1 | 217 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 405 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tecnimed S.R.L. took a median 405 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 209 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 4 | 4 |
| OSG | Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch | 1 | 0 |
Review panels
- General Hospital (4)
- Neurology (1)
Most recent Tecnimed S.R.L. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160680 | VisioFocus Mini, VisioFocus Smart | FLL | 2017-04-19 | 405 |
| K122412 | VISIOFOCUS | FLL | 2013-03-13 | 217 |
| K072108 | MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES | FLL | 2007-08-31 | 30 |
| K033790 | THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES | FLL | 2004-06-03 | 182 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN130019 | De Novo | Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch | 2014-11-07 |
Recalls
openFDA lists no recalls under a recalling firm named Tecnimed S.R.L..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Tecnimed S.R.L.?
FDA lists 4 510(k) clearances under the applicant name “Tecnimed S.R.L.” (first 2004, latest 2017), plus 1 De Novo decision, across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tecnimed S.R.L.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tecnimed S.R.L. is 200 days.
Which FDA product codes appear under Tecnimed S.R.L.?
The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 4); OSG (Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch, 1).
Next steps
- See all 4 Tecnimed S.R.L. clearances with predicates and recalls
- Run predicate analysis for product code FLL, Tecnimed S.R.L.'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.