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

Hemometrix — Predicate Candidate Screening

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

39 daysmedian FDA review time

39 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K800037	PLATELET RETENTION (ADHESION) COLUMNS	Hemometrix	1980-02-05	29
K792262	GENTAMICIN LIQUID CONTROL SERUM	Hemometrix	1979-12-18	39
K792261	GENTAMICIN CONTROL SERUM	Hemometrix	1979-12-18	39
K792263	TOBRAMYCIN CONTROL SERUM	Hemometrix	1979-12-18	39
K792264	TOBRAMYCIN LIQUID CONTROL SERUM	Hemometrix	1979-12-18	39
K792259	AMIKACIN CONTROL SERUM	Hemometrix	1979-12-18	39
K792260	AMIKACIN LIQUID CONTROL SERUM	Hemometrix	1979-12-18	39

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