Atlas FDA

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

Lerado China Limited — Predicate Candidate Screening

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

41 daysmedian FDA review time
89 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K070817LERADOTECH SCOOTER, MODEL SBLerado China Limited2007-04-13180
K070802LERADOTECH, MODEL SCLerado China Limited2007-04-13210
K070433LERADO, POWER WHEELCHAIR, PBLerado China Limited2007-03-16300
K060068AVANTICARE, MODEL SA4021Lerado China Limited2006-03-08580
K051473LEARDO, AVANTICARE ELECTRICAL SCOOTERSM3021Lerado China Limited2005-08-31890
K051538AVANTICARE, MODEL SA4022Lerado China Limited2005-07-21410

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