Atlas FDA

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

Environmental Diagnostics, Inc. — Predicate Candidate Screening

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

52 daysmedian FDA review time
159 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K905700EZ-SCREEN: AMPHETAMINESEnvironmental Diagnostics, Inc.1991-01-15260
K905057EZ-SCREEN:BARBITURATESEnvironmental Diagnostics, Inc.1990-11-28200
K902681EZ-SCREEN:HCGEnvironmental Diagnostics, Inc.1990-08-09510
K900203EZ-SCREEN:OPIATESEnvironmental Diagnostics, Inc.1990-03-09520
K883105EZ-SCREEN CANNABINOID/COCAINEEnvironmental Diagnostics, Inc.1988-12-161440
K862916EZ-SCREEN: CANNABINOIDEnvironmental Diagnostics, Inc.1987-01-071590

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