Amplifon S.P.A.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Amplifon S.P.A.” (first 1997, latest 1999), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 87 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EWO | Audiometer | 4 | 4 |
| ETY | Tester, Auditory Impedance | 2 | 2 |
| GWF | Stimulator, Electrical, Evoked Response | 2 | 2 |
Review panels
- Ear, Nose and Throat (6)
- Neurology (2)
Most recent Amplifon S.P.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992370 | AMPLAID A724 AND A728 | ETY | 1999-09-20 | 67 |
| K983915 | AMPLAID A315 AND A319 | EWO | 1999-01-29 | 86 |
| K983712 | AMPLAID A311 SERIES | EWO | 1999-01-12 | 83 |
| K971740 | AMPLAID MK12 | GWF | 1998-03-16 | 308 |
| K974235 | AMPLAID AM50 | ETY | 1998-02-10 | 90 |
| K972959 | AMPLAID MK22 | GWF | 1998-02-06 | 179 |
| K972862 | AMPLAID 171S | EWO | 1997-10-31 | 88 |
| K971747 | AMPLAID 460 | EWO | 1997-08-05 | 85 |
Recalls
openFDA lists no recalls under a recalling firm named Amplifon S.P.A..
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 Amplifon S.P.A.?
FDA lists 8 510(k) clearances under the applicant name “Amplifon S.P.A.” (first 1997, latest 1999), across 3 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 Amplifon S.P.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Amplifon S.P.A. is 87 days.
Which FDA product codes appear under Amplifon S.P.A.?
The most frequent FDA product codes under this applicant name are EWO (Audiometer, 4); ETY (Tester, Auditory Impedance, 2); GWF (Stimulator, Electrical, Evoked Response, 2).
Next steps
- See all 8 Amplifon S.P.A. clearances with predicates and recalls
- Run predicate analysis for product code EWO, Amplifon S.P.A.'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.