Alber GmbH: FDA clearances and approvals
Alber GmbH has 5 FDA 510(k) clearances (first 2016, latest 2022), across 1 product code in 1 review panel. Median 510(k) review time: 243 days. Since 2017 its median was 295 days, against 122 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 2 | 200 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 350 |
| 2021 | 0 | — |
| 2022 | 1 | 27 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Alber GmbH's cleared 510(k)s took a median 295 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ITI | Wheelchair, Powered | 5 | 5 |
Review panels
Most recent Alber GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221215 | e-motion M25 | ITI | 2022-05-24 | 27 |
| K192618 | e-Motion M25 | ITI | 2020-11-02 | 406 |
| K192016 | SMOOV O10 | ITI | 2020-05-19 | 295 |
| K161241 | e-fix E35/E36 | ITI | 2016-10-05 | 156 |
| K151717 | twion | ITI | 2016-02-23 | 243 |
Recalls
openFDA lists no recalls under a recalling firm named Alber GmbH.
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 Alber GmbH have?
Alber GmbH has 5 FDA 510(k) clearances (first 2016, latest 2022), across 1 product code in 1 review panel.
How long does FDA take to clear Alber GmbH's 510(k)s?
The median time from FDA receipt to decision across Alber GmbH's cleared 510(k)s is 243 days. Since 2017: 295 days, versus 122 days for all cleared 510(k)s in the same product codes.
What devices does Alber GmbH make?
Its most frequent FDA product codes are ITI (Wheelchair, Powered, 5).
Has Alber GmbH had device recalls?
openFDA lists no recalls under a recalling firm name matching Alber GmbH. Related entities may recall under other names.
Next steps
- See all 5 Alber GmbH clearances with predicates and recalls
- Run predicate analysis for product code ITI, Alber GmbH'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.