Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Berkeley Electric Wheelchair Co. · Predicate Candidate Screening

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

17 daysmedian FDA review time
94 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K823085BERKELEY CHAIRBerkeley Electric Wheelchair Co.1983-01-21940
K823873CHAIN SILENCERBerkeley Electric Wheelchair Co.1983-01-14170
K823874BERKELEY BRAKEBerkeley Electric Wheelchair Co.1983-01-14170
K823875CHAIN KITBerkeley Electric Wheelchair Co.1983-01-14170
K823876BERKELEY FORKBerkeley Electric Wheelchair Co.1983-01-14170
K823877BERKELEY HARNESSBerkeley Electric Wheelchair Co.1983-01-14170

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