Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oxehealth Limited · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
271 daysmedian FDA review time
364 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251200 | Vital Signs | Oxehealth Limited | 2026-02-02 | 290 | 0 |
| K243687 | Vital Signs | Oxehealth Limited | 2025-08-27 | 271 | 0 |
| K233618 | Oxevision Sleep Device | Oxehealth Limited | 2024-04-03 | 142 | 0 |
| K220899 | Oxehealth Vital Signs | Oxehealth Limited | 2022-04-29 | 32 | 0 |
| K211906 | Vital Signs | Oxehealth Limited | 2021-07-20 | 29 | 0 |
| DEN200019 | Oxehealth Vital Signs | Oxehealth Limited | 2021-03-26 | 364 | 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