Club Hearing Instruments A/S: FDA clearances and approvals
Club Hearing Instruments A/S has 5 FDA 510(k) clearances (first 1992, latest 1992), across 1 product code in 1 review panel. Median 510(k) review time: 83 days.
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 | 5 | 5 |
Review panels
Most recent Club Hearing Instruments A/S 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K923292 | ITC HEARING AID CLUB MODEL LM50 | ESD | 1992-10-05 | 95 |
| K923296 | BTE HEARING AID CLUB MODEL ST70 | ESD | 1992-09-23 | 83 |
| K923295 | ITC HEARING AID CLUB MODEL LM40 | ESD | 1992-09-23 | 83 |
| K923294 | BTE HEARING AID CLUB MODEL: ST60 | ESD | 1992-09-23 | 83 |
| K923293 | ITC HEARING AID CLUB MODEL LM50H | ESD | 1992-09-23 | 83 |
Recalls
openFDA lists no recalls under a recalling firm named Club Hearing Instruments A/S.
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 Club Hearing Instruments A/S have?
Club Hearing Instruments A/S has 5 FDA 510(k) clearances (first 1992, latest 1992), across 1 product code in 1 review panel.
How long does FDA take to clear Club Hearing Instruments A/S's 510(k)s?
The median time from FDA receipt to decision across Club Hearing Instruments A/S's cleared 510(k)s is 83 days.
What devices does Club Hearing Instruments A/S make?
Its most frequent FDA product codes are ESD (Hearing Aid, Air-Conduction, Prescription, 5).
Has Club Hearing Instruments A/S had device recalls?
openFDA lists no recalls under a recalling firm name matching Club Hearing Instruments A/S. Related entities may recall under other names.
Next steps
- See all 5 Club Hearing Instruments A/S clearances with predicates and recalls
- Run predicate analysis for product code ESD, Club Hearing Instruments A/S'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.