Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Onera B.V. — 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) |
|---|---|---|---|---|---|
| K253668 | Onera SleepMap (SLEEPMAP) | Onera B.V. | 2026-03-08 | 107 | 0 |
| K243220 | Onera STS 2 (ONERA STS 2) | Onera B.V. | 2025-07-03 | 269 | 0 |
| K223573 | Onera Sleep Test System (Onera STS) | Onera B.V. | 2023-08-18 | 261 | 0 |
| K210593 | Onera Sleep Test System (Onera STS) | Onera B.V. | 2022-04-06 | 401 | 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