Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Nox Medical Ehf · Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

169 daysmedian FDA review time
254 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260585Noxturnal WebNox Medical Ehf2026-03-20280
K252330DeepRESPNox Medical Ehf2025-11-171150
K241960DeepRESPNox Medical Ehf2025-03-142540
K241288Noxturnal WebNox Medical Ehf2024-12-232300
K151361Nox RIP Belts & CablesNox Medical Ehf2015-11-061690

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