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

Ortho Instruments — Predicate Candidate Screening

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

38 daysmedian FDA review time

66 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days
K803083	ORTHO HEMOTOLOGY CONTROL-NORMAL	Ortho Instruments	1980-12-31	26
K803073	ORTHO HEMATOLOGY CONTROL	Ortho Instruments	1980-12-31	26
K803084	ORTHO HEMATOLOGY CONTROL ABNORMAL LOW	Ortho Instruments	1980-12-31	26
K802094	ORTHO SPECTRUM	Ortho Instruments	1980-10-10	38
K801545	ORTHO AUTOMATED CELL COUNTER	Ortho Instruments	1980-09-09	64
K781146	HEMAC LASER HEMATOLOGY SYSTEM	Ortho Instruments	1978-09-14	66

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