Atlas FDA

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

Editek, Inc. — Predicate Candidate Screening

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

73 daysmedian FDA review time
108 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K963692VERDICT PCPEditek, Inc.1996-12-10850
K963233EZ-SCREEN PROFILEEditek, Inc.1996-10-31730
K963529VERDICT BARBITURATESEditek, Inc.1996-10-30560
K963516VERDICT THCEditek, Inc.1996-10-30570
K943712VERDICT OPIATESEditek, Inc.1994-11-171080
K943710VERDICT COCAINEEditek, Inc.1994-11-171080
K943711EZ-SCREEN:PCPEditek, Inc.1994-09-09390

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