Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QZW — Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261011 | Sleep Apnea Feature (v2.0) | Samsung Electronics Co., Ltd. | 2026-07-20 | 116 | 0 |
| K240929 | Sleep Apnea Notification Feature (SANF) | Apple, Inc. | 2024-09-13 | 162 | 0 |
| DEN230041 | Sleep Apnea Feature | Samsung Electronics Co., Ltd. | 2024-02-06 | 251 | 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