Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
R82 A/S — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
352 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151492 | Kudu | R82 A/S | 2016-05-20 | 352 | 0 |
| K100084 | MULTI FRAME WHEELCHAIR | R82 A/S | 2010-04-12 | 90 | 0 |
| K061810 | COUGAR WHEELCHAIR | R82 A/S | 2006-08-07 | 41 | 0 |
| K033460 | CHEETAH WHEELCHAIR | R82 A/S | 2004-03-26 | 148 | 0 |
| K030882 | RABBIT MOBILE STANDING FRAME | R82 A/S | 2003-04-04 | 15 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda