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

Quantimetrix Medical Industries — Predicate Candidate Screening

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

48 daysmedian FDA review time

105 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K895778	QUANTIMETRIX BILIRUBIN CALIBRATORS	Quantimetrix Medical Industries	1989-11-14	48	0
K883395	ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY	Quantimetrix Medical Industries	1988-09-19	39	0
K883247	LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL	Quantimetrix Medical Industries	1988-09-13	42	0
K874302	QUANTIMETRIX TOTAL CREATINE KINASE CONTROL	Quantimetrix Medical Industries	1988-02-02	105	0
K874890	QUANTIMETRIX URINE DIPSTICK CONTROL	Quantimetrix Medical Industries	1988-01-21	51	2
K873011	QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2	Quantimetrix Medical Industries	1987-10-29	86	0
K873467	QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL	Quantimetrix Medical Industries	1987-09-29	32	0
K861448	QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID	Quantimetrix Medical Industries	1986-04-28	47	0

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