Atlas FDA

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

Earl-Clay Laboratories, Inc. — Predicate Candidate Screening

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

39 daysmedian FDA review time
50 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K861585ULTRACLONE 01-2300 CELL LINEEarl-Clay Laboratories, Inc.1986-05-13140
K861569ULTRACLONE 01-700 CELL LINEEarl-Clay Laboratories, Inc.1986-05-0570
K854206ULTRACLONE 05-100 GUINEA PIG RBCEarl-Clay Laboratories, Inc.1985-10-31150
K853203ULTRACLONE ECL-01-2200 CELL LINEEarl-Clay Laboratories, Inc.1985-08-12130
K851545ULTRACLONE ECL-01-800 CELL LINEEarl-Clay Laboratories, Inc.1985-05-10240
K843577ULTRAXLONE ECL-01-1000 CELL LINEEarl-Clay Laboratories, Inc.1984-10-31500
K843579ULTRACLONE ECL-01-1100Earl-Clay Laboratories, Inc.1984-10-31500
K843578ULTRACLONE ECL-01-2100 CELL LINEEarl-Clay Laboratories, Inc.1984-10-31500
K843862ULTRACLONE ECL-01-900 CELL LINEEarl-Clay Laboratories, Inc.1984-10-17150
K843863ULTRACLONE ECL-01-1300 CELL LINEEarl-Clay Laboratories, Inc.1984-10-17150
K843864ULTRACLONE ECL-01-1400 CELL LINEEarl-Clay Laboratories, Inc.1984-10-17150
K841337ULTRACLONE ECL-01-800 CELL LINEEarl-Clay Laboratories, Inc.1984-05-11390
K841341ULTRACLONE ECL-01-1000 CELL LINEEarl-Clay Laboratories, Inc.1984-05-11390
K841339ULTRA CLONE ECL-01-700 CELL LINEEarl-Clay Laboratories, Inc.1984-05-11390
K841342ULTRACLONE ECL-01-400 CELL LINEEarl-Clay Laboratories, Inc.1984-05-11390
K841343ULTRACLONE ECL-01-100 CELL LINEEarl-Clay Laboratories, Inc.1984-05-11390
K841338ULTRACLONE ECL-01-600 CELL LINEEarl-Clay Laboratories, Inc.1984-05-11390
K841346ULTRACLONE ECL-01-200 CELL LINEEarl-Clay Laboratories, Inc.1984-05-11390
K841340ULTRACLONE ECL-01-900 CELL LINEEarl-Clay Laboratories, Inc.1984-05-11390
K841345ULTRACLONE ECL-01-500 CELL LINEEarl-Clay Laboratories, Inc.1984-05-11390
K841344ULTRACLONE ECL-01-300 CELL LINEEarl-Clay Laboratories, Inc.1984-05-11390

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