Atlas FDA

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

Amdia Medical Products · Predicate Candidate Screening

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

21 daysmedian FDA review time
21 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K791334MULTISCOPEAmdia Medical Products1979-08-10210
K791333BOWLES STETHOSCOPEAmdia Medical Products1979-08-10210
K791335NURSESCOPEAmdia Medical Products1979-08-10210
K791338DUAL HEAD STETHOSCOPEAmdia Medical Products1979-08-10210
K791337TAYLOR NEUROLOGICAL HAMMERAmdia Medical Products1979-08-03140
K791336BUCKS NEUROLOGICAL HAMMERAmdia Medical Products1979-08-03140

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