Ototronix, LLC: FDA clearances and approvals
Ototronix, LLC has 2 FDA 510(k) clearances (first 2013, latest 2014), plus 1 PMA decision, across 3 product codes in 2 review panels. Median 510(k) review time: 93 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 88 |
| 2014 | 1 | 98 |
| 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 |
|---|---|---|---|
| GWN | Nystagmograph | 1 | 1 |
| MPV | Implant, Hearing, Active, Middle Ear, Partially Implanted | 1 | 0 |
| NEA | Cement, Ear, Nose And Throat | 1 | 1 |
Review panels
- Ear, Nose and Throat (2)
- Neurology (1)
Most recent Ototronix, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140644 | PROCEM | NEA | 2014-06-19 | 98 |
| K130201 | NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM | GWN | 2013-04-26 | 88 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P010023 | PMA | SOUNDTEC DIRECT SYSTEM | 2001-09-07 |
Recalls
openFDA lists no recalls under a recalling firm named Ototronix, LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Ototronix, LLC have?
Ototronix, LLC has 2 FDA 510(k) clearances (first 2013, latest 2014), plus 1 PMA decision, across 3 product codes in 2 review panels.
How long does FDA take to clear Ototronix, LLC's 510(k)s?
The median time from FDA receipt to decision across Ototronix, LLC's cleared 510(k)s is 93 days.
What devices does Ototronix, LLC make?
Its most frequent FDA product codes are GWN (Nystagmograph, 1); MPV (Implant, Hearing, Active, Middle Ear, Partially Implanted, 1); NEA (Cement, Ear, Nose And Throat, 1).
Has Ototronix, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Ototronix, LLC. Related entities may recall under other names.
Next steps
- See all 2 Ototronix, LLC clearances with predicates and recalls
- Run predicate analysis for product code GWN, Ototronix, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.