Interacoustics A/S: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Interacoustics A/S” (first 2006, latest 2020), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 133 days. Since 2017 the median was 163 days, against 148 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 | 1 | 157 |
| 2013 | 2 | 89 |
| 2014 | 0 | — |
| 2015 | 2 | 92 |
| 2016 | 0 | — |
| 2017 | 2 | 206 |
| 2018 | 1 | 86 |
| 2019 | 1 | 54 |
| 2020 | 3 | 163 |
| 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 Interacoustics A/S took a median 163 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 148 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GWN | Nystagmograph | 5 | 5 |
| EWO | Audiometer | 4 | 4 |
| GWJ | Stimulator, Auditory, Evoked Response | 3 | 3 |
| LXV | Apparatus, Vestibular Analysis | 3 | 3 |
| ETY | Tester, Auditory Impedance | 2 | 2 |
Review panels
- Ear, Nose and Throat (9)
- Neurology (8)
Most recent Interacoustics A/S 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200534 | VisualEyes | GWN | 2020-08-12 | 163 |
| K200529 | Orion | LXV | 2020-08-12 | 163 |
| K192652 | TRV | LXV | 2020-05-27 | 246 |
| K191372 | Lyra | EWO | 2019-07-15 | 54 |
| K173567 | Sera | EWO | 2018-02-14 | 86 |
| K163149 | VisualEyes | GWN | 2017-04-26 | 168 |
| K162037 | Eclipse with VEMP | GWJ | 2017-03-23 | 244 |
| K152112 | VisualEyes | GWN | 2015-12-29 | 153 |
| K151616 | AT235 | ETY | 2015-07-15 | 30 |
| K131681 | EYESEECAM VHIT | GWN | 2013-09-06 | 88 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Interacoustics A/S.
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.
- Interacoustics A/S, Assens (4 510(k)s)
- Interacoustics AS (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Interacoustics A/S?
FDA lists 17 510(k) clearances under the applicant name “Interacoustics A/S” (first 2006, latest 2020), across 5 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 Interacoustics A/S?
The median time from FDA receipt to decision across 510(k)s cleared under the name Interacoustics A/S is 133 days. Since 2017: 163 days, versus 148 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Interacoustics A/S?
The most frequent FDA product codes under this applicant name are GWN (Nystagmograph, 5); EWO (Audiometer, 4); GWJ (Stimulator, Auditory, Evoked Response, 3).
Next steps
- See all 17 Interacoustics A/S clearances with predicates and recalls
- Run predicate analysis for product code GWN, Interacoustics A/S'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.