Gn Otometrics: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Gn Otometrics” (first 2008, latest 2016), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 90 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 | 2 | 89 |
| 2013 | 1 | 164 |
| 2014 | 1 | 160 |
| 2015 | 1 | 165 |
| 2016 | 1 | 72 |
| 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 |
|---|---|---|---|
| GWJ | Stimulator, Auditory, Evoked Response | 3 | 3 |
| GWN | Nystagmograph | 2 | 2 |
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 1 | 1 |
| ETY | Tester, Auditory Impedance | 1 | 1 |
| EWO | Audiometer | 1 | 1 |
Review panels
- Neurology (5)
- Ear, Nose and Throat (3)
Most recent Gn Otometrics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161707 | Madsen Zodiac | ETY | 2016-09-01 | 72 |
| K151504 | ICS Impulse | GWN | 2015-11-16 | 165 |
| K132957 | MADSEN ACCUSCREEN TYPE 1077 | GWJ | 2014-02-27 | 160 |
| K122550 | ICS IMPULSE | GWN | 2013-02-01 | 164 |
| K122028 | AURICAL HIT | ETW | 2012-10-23 | 105 |
| K122067 | TYPE 1077 ACCUSCREEN | GWJ | 2012-09-27 | 73 |
| K092373 | ICS CHARTR EP 200 | GWJ | 2009-09-03 | 29 |
| K081234 | GN OTOMETRICS INSERT EARPHONES | EWO | 2008-07-14 | 74 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2019-08-01.
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 Gn Otometrics?
FDA lists 8 510(k) clearances under the applicant name “Gn Otometrics” (first 2008, latest 2016), 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 Gn Otometrics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gn Otometrics is 90 days.
Which FDA product codes appear under Gn Otometrics?
The most frequent FDA product codes under this applicant name are GWJ (Stimulator, Auditory, Evoked Response, 3); GWN (Nystagmograph, 2); ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems, 1).
Next steps
- See all 8 Gn Otometrics clearances with predicates and recalls
- Run predicate analysis for product code GWJ, Gn Otometrics'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.