Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Circadiance, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
288 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162905 | SleepWeaver 3D Nasal Mask | Circadiance, LLC | 2017-03-15 | 149 | 0 |
| K151683 | SleepWeaver Advance Pediatric Nasal CPAP Mask | Circadiance, LLC | 2016-04-05 | 288 | 0 |
| K130481 | SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK | Circadiance, LLC | 2013-05-24 | 88 | 0 |
| K120757 | SLEEPWEAVER ELAN NASAL CPAP MASK | Circadiance, LLC | 2012-04-24 | 42 | 0 |
| K092362 | SLEEPWEAVER NASAL CPAP MASK | Circadiance, LLC | 2009-11-02 | 90 | 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