Bose Corporation: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Bose Corporation” (first 2021, latest 2021), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 30 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 |
|---|---|---|
| 2021 | 1 | 30 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bose Corporation took a median 30 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 162 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QDD | Self-Fitting Air-Conduction Hearing Aid, Prescription | 2 | 1 |
Review panels
Most recent Bose Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211008 | Bose SoundControl Hearing Aids | QDD | 2021-05-05 | 30 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN180026 | De Novo | Self-Fitting Air-Conduction Hearing Aid, Prescription | 2018-10-05 |
Recalls
openFDA lists no recalls under a recalling firm named Bose Corporation.
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 Bose Corporation?
FDA lists 1 510(k) clearance under the applicant name “Bose Corporation” (first 2021, latest 2021), plus 1 De Novo decision, 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 Bose Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bose Corporation is 30 days.
Which FDA product codes appear under Bose Corporation?
The most frequent FDA product codes under this applicant name are QDD (Self-Fitting Air-Conduction Hearing Aid, Prescription, 2).
Next steps
- See all 1 Bose Corporation clearances with predicates and recalls
- Run predicate analysis for product code QDD, Bose Corporation'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.