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

Applied Laboratories, Inc. — Predicate Candidate Screening

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

185 daysmedian FDA review time
185 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K873824RED #467, #457, BLUE #437, GREEN #447 MINDEL S1000Applied Laboratories, Inc.1988-03-241850
K873823MOBAY (BAYER) MAKROLON 2658 3291Applied Laboratories, Inc.1988-03-241850
K873820MOBAY (BAYER) MAKROLON 2658 1112Applied Laboratories, Inc.1988-03-241850
K873825GE LEXAN 144R 112Applied Laboratories, Inc.1988-03-241850
K873821GE NORYL 731-80089SApplied Laboratories, Inc.1988-03-241850
K873822MOBAY (BAYER) MERLON M-40 (H)F 1112Applied Laboratories, Inc.1988-03-241850
K871714KESTREL CONTACT LENS CASEApplied Laboratories, Inc.1987-05-26220
K860677EASY EYES TM LENS CARRYING CASEApplied Laboratories, Inc.1986-05-29930
K853870EASY EYES TM LENS CARRYING CASEApplied Laboratories, Inc.1985-12-10840

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