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

Omega Medical Electronics — Predicate Candidate Screening

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

77 daysmedian FDA review time

86 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days
K823691	PHOSPHORUS REAGENT SET	Omega Medical Electronics	1983-01-07	30
K821206	SGPT-UV REAGENT SET	Omega Medical Electronics	1982-07-22	86
K821212	UREA NITROGEN REAGENT SET	Omega Medical Electronics	1982-07-22	86
K821204	GLUCOSE(ENZYMATIC) REAGENT SET	Omega Medical Electronics	1982-07-22	86
K821201	LDH-UV REAGENT SET	Omega Medical Electronics	1982-07-20	84
K821205	TRIGLYCERIDE REAGENT SET	Omega Medical Electronics	1982-07-20	84
K821208	SGOT-UV REAGENT SET	Omega Medical Electronics	1982-07-20	84
K821209	SGOT REAGENT SET	Omega Medical Electronics	1982-07-14	78
K821207	SGPT REAGENT SET	Omega Medical Electronics	1982-07-14	78
K821199	CREATININE REAGENT SET	Omega Medical Electronics	1982-07-13	77
K821213	URIC ACID REAGENT SET	Omega Medical Electronics	1982-07-13	77
K821193	ALBUMIN REAGENT SET	Omega Medical Electronics	1982-07-13	77
K821195	CHOLESTEROL REAGENT SET	Omega Medical Electronics	1982-07-13	77
K821203	HDL PRECIPITANT REAGENT SET	Omega Medical Electronics	1982-07-13	77
K821197	TOTAL BILIRUBIN REAGENT SET	Omega Medical Electronics	1982-07-13	77
K821198	DIRECT GLUCOSE REAGENT SET	Omega Medical Electronics	1982-07-13	77
K821210	SERUM TOTAL PROTEIN REAGENT SET	Omega Medical Electronics	1982-07-13	77
K821200	ALKALINE PHOSPHOTASE REAGENT SET	Omega Medical Electronics	1982-07-13	77
K821196	SERUM CALCIUM REAGENT SET	Omega Medical Electronics	1982-07-13	77
K821202	HEMOGLOBIN REAGENT SET	Omega Medical Electronics	1982-05-24	27
K821214	URIC ACID REAGENT SET(ENZYMATIC	Omega Medical Electronics	1982-05-21	24

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