Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nox Medical · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192469 | Nox Sleep System | Nox Medical | 2019-11-13 | 65 | 0 |
| K124062 | QDC-PRO, AND NOX-RIP | Nox Medical | 2013-07-10 | 191 | 0 |
| K082113 | NOX T3, NOXTURNAL (PC APPLICATION) | Nox Medical | 2008-11-07 | 102 | 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