Sophono, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Sophono, Inc.” (first 2010, latest 2016), across 1 product code in 1 review panel. Median 510(k) review time under this name: 130 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 | 2 | 116 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 205 |
| 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 |
|---|---|---|---|
| LXB | Hearing Aid, Bone Conduction | 5 | 5 |
Review panels
Most recent Sophono, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153391 | Sophono Bone Conduction Systems (S) Configuration and (M) Configuration | LXB | 2016-06-16 | 205 |
| K132189 | OTOMAG BONE CONDUCATION HEARING SYSTEM | LXB | 2013-11-22 | 130 |
| K123962 | OTOMAG BONE CONDUCTION HEARING SYSTEM | LXB | 2013-04-08 | 103 |
| K102199 | OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M) | LXB | 2011-05-23 | 292 |
| K100193 | OTOMAG BONE CONDUCTION HEARING SYSTEM | LXB | 2010-05-18 | 116 |
Recalls
openFDA lists no recalls under a recalling firm named Sophono, Inc..
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 Sophono, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Sophono, Inc.” (first 2010, latest 2016), 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 Sophono, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sophono, Inc. is 130 days.
Which FDA product codes appear under Sophono, Inc.?
The most frequent FDA product codes under this applicant name are LXB (Hearing Aid, Bone Conduction, 5).
Next steps
- See all 5 Sophono, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LXB, Sophono, Inc.'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.