Otodynamics, Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Otodynamics, Ltd.” (first 1997, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 84 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 | 1 | 89 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 104 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Otodynamics, Ltd. took a median 104 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EWO | Audiometer | 8 | 8 |
Review panels
Most recent Otodynamics, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K234095 | OtoNova/OtoNova Pro | EWO | 2024-06-21 | 178 |
| K240430 | Otoport Pro | EWO | 2024-03-15 | 30 |
| K143395 | Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit | EWO | 2015-02-23 | 89 |
| K072033 | OTODYNAMICS OTOPORT | EWO | 2007-11-13 | 112 |
| K983352 | ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK | EWO | 1998-12-11 | 79 |
| K983351 | ILO292 DP ECHOPORT PLUS OAE SYSTEM | EWO | 1998-12-11 | 79 |
| K983350 | ILO292 DP ECHOPORT PLUS OAE SYSTEM | EWO | 1998-12-11 | 79 |
| K962995 | ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC | EWO | 1997-01-10 | 162 |
Recalls
openFDA lists no recalls under a recalling firm named Otodynamics, Ltd..
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 Otodynamics, Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Otodynamics, Ltd.” (first 1997, latest 2024), 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 Otodynamics, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Otodynamics, Ltd. is 84 days.
Which FDA product codes appear under Otodynamics, Ltd.?
The most frequent FDA product codes under this applicant name are EWO (Audiometer, 8).
Next steps
- See all 8 Otodynamics, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EWO, Otodynamics, Ltd.'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.