Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OZR · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
301 daysmedian FDA review time
444 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220907 | The iNAP One Sleep Therapy System | Somnics, Inc. | 2023-06-16 | 444 | 0 |
| K193460 | The iNAP One Sleep Therapy System | Somnice, Inc. | 2020-05-26 | 162 | 0 |
| K132003 | WINX SLEEP THERAPY SYSTEM | Apnicure, Inc. | 2014-06-13 | 347 | 0 |
| K130538 | WINX SLEEP THERAPY SYSTEM | Apnicure, Inc. | 2013-05-22 | 82 | 0 |
| K122130 | WINX SLEEP THERAPY SYSTEM | Apnicure, Inc. | 2012-10-31 | 105 | 0 |
| K111549 | ATTUNE SLEEP APNEA SYSTEM | Apnicure, Inc. | 2012-03-30 | 301 | 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