Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Huxley Medical — 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) |
|---|---|---|---|---|---|
| K252497 | SANSA HSAT | Huxley Medical | 2025-12-10 | 124 | 0 |
| K250882 | SANSA HSAT | Huxley Medical | 2025-10-29 | 219 | 0 |
| K244027 | SANSA HSAT | Huxley Medical | 2025-01-28 | 29 | 0 |
| K240285 | Huxley SANSA Home Sleep Apnea Test (1000-00) | Huxley Medical | 2024-07-15 | 165 | 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