Medax Srl Unipersonale: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Medax Srl Unipersonale” (first 2015, latest 2020), across 1 product code in 1 review panel. Median 510(k) review time under this name: 241 days. Since 2017 the median was 173 days, against 122 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 |
|---|---|---|
| 2015 | 1 | 505 |
| 2016 | 0 | — |
| 2017 | 1 | 103 |
| 2018 | 1 | 105 |
| 2019 | 0 | — |
| 2020 | 2 | 241 |
| 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 Medax Srl Unipersonale took a median 173 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNW | Instrument, Biopsy | 5 | 5 |
Review panels
Most recent Medax Srl Unipersonale 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192101 | Medone Ultra, Medextra | KNW | 2020-04-02 | 241 |
| K192099 | MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System | KNW | 2020-04-02 | 241 |
| K181803 | Medax Biopsy Systems III | KNW | 2018-10-18 | 105 |
| K172344 | Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) | KNW | 2017-11-13 | 103 |
| K142125 | New Medax Biopsy Systems | KNW | 2015-12-22 | 505 |
Recalls
openFDA lists no recalls under a recalling firm named Medax Srl Unipersonale.
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.
- Medax Unipersonale Srl (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medax Srl Unipersonale?
FDA lists 5 510(k) clearances under the applicant name “Medax Srl Unipersonale” (first 2015, latest 2020), across 1 product code 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 Medax Srl Unipersonale?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medax Srl Unipersonale is 241 days. Since 2017: 173 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medax Srl Unipersonale?
The most frequent FDA product codes under this applicant name are KNW (Instrument, Biopsy, 5).
Next steps
- See all 5 Medax Srl Unipersonale clearances with predicates and recalls
- Run predicate analysis for product code KNW, Medax Srl Unipersonale'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.