Atlas FDA

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

Omega Medical Diagnostics · Predicate Candidate Screening

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

36 daysmedian FDA review time
70 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K832182LYSING REAGENTOmega Medical Diagnostics1983-08-12360
K831620SODIUM HYPOCHLORITE 3%Omega Medical Diagnostics1983-07-28700
K831619SODIUM HYPOCHLORITE 7%Omega Medical Diagnostics1983-07-28700
K831618HEMOGLOBIN REAGENTOmega Medical Diagnostics1983-06-16280
K831617DILUENTOmega Medical Diagnostics1983-06-16280

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