R82 A/S: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “R82 A/S” (first 2003, latest 2016), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 90 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 352 |
| 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 |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | 4 | 4 |
| IPL | Wheelchair, Standup | 1 | 1 |
Review panels
Most recent R82 A/S 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151492 | Kudu | IOR | 2016-05-20 | 352 |
| K100084 | MULTI FRAME WHEELCHAIR | IOR | 2010-04-12 | 90 |
| K061810 | COUGAR WHEELCHAIR | IOR | 2006-08-07 | 41 |
| K033460 | CHEETAH WHEELCHAIR | IOR | 2004-03-26 | 148 |
| K030882 | RABBIT MOBILE STANDING FRAME | IPL | 2003-04-04 | 15 |
Recalls
4 product recalls in 4 recall events; 1 initiated in the last five years. Most recent: 2021-12-08.
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 R82 A/S?
FDA lists 5 510(k) clearances under the applicant name “R82 A/S” (first 2003, latest 2016), across 2 product codes 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 R82 A/S?
The median time from FDA receipt to decision across 510(k)s cleared under the name R82 A/S is 90 days.
Which FDA product codes appear under R82 A/S?
The most frequent FDA product codes under this applicant name are IOR (Wheelchair, Mechanical, 4); IPL (Wheelchair, Standup, 1).
Next steps
- See all 5 R82 A/S clearances with predicates and recalls
- Run predicate analysis for product code IOR, R82 A/S'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.