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

Miami Eye Technology, Inc. — Predicate Candidate Screening

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

64 daysmedian FDA review time
134 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K841101CLAYMAN-PAREL CAPSULE COUPEURMiami Eye Technology, Inc.1984-05-16640
K832912GELENDER VACUUM FIXATION RING SYSMiami Eye Technology, Inc.1984-01-101340
K832996SURGICAL IOP MONITORMiami Eye Technology, Inc.1983-11-28870
K832997EPA AUTOMATED INFUSION POLEMiami Eye Technology, Inc.1983-10-04320
K832911ABBOTT GLOBE HOLDERMiami Eye Technology, Inc.1983-09-29310
K831702RARE-EARTH INTRA-OCULAR MAGNETMiami Eye Technology, Inc.1983-06-30360

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