Atlas FDA

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

Medical Illumination, Inc. — Predicate Candidate Screening

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

266 daysmedian FDA review time
293 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K931646MI-4 VARIABLE SPOT LIGHTMedical Illumination, Inc.1993-08-191390
K931026MI-5 DIAGNOSTIC LIGHTMedical Illumination, Inc.1993-08-191710
K930897MI-15 EXAM SURGICAL LIGHTMedical Illumination, Inc.1993-06-251230
K925710M.E.D. LIGHTMedical Illumination, Inc.1993-06-042040
K922278ILLUMINATOR IIIMedical Illumination, Inc.1993-03-042930
K922282ILLUMINATOR VIII ULTRA/SPOTMedical Illumination, Inc.1993-03-042930
K922280ILLUMINATOR VII MINI/LUM LIGHTMedical Illumination, Inc.1993-02-052660
K922281ILLUMINATOR VII MINI/SPOT LIGHTMedical Illumination, Inc.1993-02-052660
K922277ILLUMINATOR IIMedical Illumination, Inc.1993-02-052660
K922279ILLUMINATOR IV MINOR SURGERY LIGHTMedical Illumination, Inc.1992-09-021100

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