Ototech, Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Ototech, Ltd.” (first 1991, latest 2001), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 53 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 |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | 4 | 4 |
| NEA | Cement, Ear, Nose And Throat | 1 | 1 |
Review panels
Most recent Ototech, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011338 | OTO-CEM | NEA | 2001-09-13 | 134 |
| K910314 | C ABRA MODEL LINEAR, LOW DR. CUSTOM CANAL HEAR AID | ESD | 1991-03-18 | 53 |
| K910313 | ABRA IPC MODEL INPUT COMPRES AGCCUST ITE HEAR AID | ESD | 1991-03-18 | 53 |
| K910312 | C ABRA MODEL LINEAR, LOW DRAIN CUST CANAL HEAR AID | ESD | 1991-03-18 | 53 |
| K910311 | ABRA MODEL LINE LOW DRAIN CUST IN-THE-EAR HEAR AID | ESD | 1991-03-18 | 53 |
Recalls
openFDA lists no recalls under a recalling firm named Ototech, 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.
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.
- Ototech Intl., Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ototech, Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Ototech, Ltd.” (first 1991, latest 2001), across 2 product codes 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 Ototech, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ototech, Ltd. is 53 days.
Which FDA product codes appear under Ototech, Ltd.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 4); NEA (Cement, Ear, Nose And Throat, 1).
Next steps
- See all 5 Ototech, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Ototech, 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.