Atlas FDA

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

Nu-Ear Electronics · Predicate Candidate Screening

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

77 daysmedian FDA review time
77 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K935329NU.EAR AE-2 IN THE CANAL (ITC) HEARING AIDNu-Ear Electronics1994-01-21770
K935334NU.EAR SD-1 IN THE EAR (ITE) HEARING AIDNu-Ear Electronics1994-01-21770
K935330NU.EAR SS-3 IN THE CANAL (ITC) HEARING AIDNu-Ear Electronics1994-01-21770
K935327NU.EAR SD-2 IN-THE-CANAL (ITC) HEARING AIDNu-Ear Electronics1994-01-21770
K935326NU-EAR SD-10 IN THE CANAL HEARING AIDNu-Ear Electronics1994-01-21770
K935335NU.EAR SS-10 IN THE CANAL (ITC) HEARING AIDNu-Ear Electronics1994-01-21770
K935333NU.EAR SS-1 IN THE EAR (ITE) HEARING AIDNu-Ear Electronics1994-01-21770
K935332NU.EAR AE-1 IN THE EAR (ITE) HEARING AIDNu-Ear Electronics1994-01-21770
K935331NU.EAR SD-3 IN THE CANAL (ITC) HEARING AIDNu-Ear Electronics1994-01-21770
K935328NU.EAR SS-2 IN THE CANAL (ITC) HEARING AIDNu-Ear Electronics1994-01-21770

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