Permobil AB: FDA clearances and approvals
Permobil AB has 15 FDA 510(k) clearances (first 1990, latest 2020), across 4 product codes in 2 review panels. Median 510(k) review time: 147 days. openFDA lists 3 product recalls by a recalling firm named Permobil AB.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 177 |
| 2014 | 0 | — |
| 2015 | 2 | 150 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 105 |
| 2020 | 1 | 346 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Permobil AB's cleared 510(k)s took a median 226 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 128 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ITI | Wheelchair, Powered | 11 | 11 |
| IPL | Wheelchair, Standup | 2 | 2 |
| HFC | Aspirator, Endocervical | 1 | 1 |
| INI | Vehicle, Motorized 3-Wheeled | 1 | 1 |
Review panels
Most recent Permobil AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190682 | Explorer Mini | IPL | 2020-02-27 | 346 |
| K191874 | F5 Corpus VS | IPL | 2019-10-25 | 105 |
| K143180 | F3 | ITI | 2015-03-27 | 143 |
| K143014 | F5 | ITI | 2015-03-25 | 156 |
| K123290 | M300 & M400 | ITI | 2013-04-17 | 177 |
| K103477 | PERMOBIL M300 / M400 | ITI | 2011-03-03 | 97 |
| K081964 | K450 POWERED WHEELCHAIR | ITI | 2008-07-29 | 19 |
| K071650 | C350 POWERED WHEELCHAIR | ITI | 2007-09-12 | 86 |
| K041219 | ELECTRO | ITI | 2004-08-04 | 86 |
| K032765 | STREET | ITI | 2004-01-30 | 147 |
5 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2018-08-15.
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 Permobil AB have?
Permobil AB has 15 FDA 510(k) clearances (first 1990, latest 2020), across 4 product codes in 2 review panels.
How long does FDA take to clear Permobil AB's 510(k)s?
The median time from FDA receipt to decision across Permobil AB's cleared 510(k)s is 147 days.
What devices does Permobil AB make?
Its most frequent FDA product codes are ITI (Wheelchair, Powered, 11); IPL (Wheelchair, Standup, 2); HFC (Aspirator, Endocervical, 1).
Has Permobil AB had device recalls?
openFDA lists 3 product recalls in 2 recall events by a recalling firm whose name matches Permobil AB; the most recent began 2018-08-15. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 15 Permobil AB clearances with predicates and recalls
- Run predicate analysis for product code ITI, Permobil AB'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.