Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oxford Biosignals Limited · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K053112 | BIOSIGN | Oxford Biosignals Limited | 2006-01-31 | 88 | 0 |
| K042309 | BIOSOMNIA-V3 | Oxford Biosignals Limited | 2004-09-08 | 14 | 0 |
| K021485 | BIOSOMNIA | Oxford Biosignals Limited | 2002-09-11 | 126 | 0 |
| K002622 | BIOSLEEP | Oxford Biosignals Limited | 2000-10-23 | 61 | 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