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

Hemotec, Inc. — Predicate Candidate Screening

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

55 daysmedian FDA review time

97 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K902081	CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL	Hemotec, Inc.	1990-07-03	56	0
K894359	CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS	Hemotec, Inc.	1989-09-05	53	0
K894317	HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.	Hemotec, Inc.	1989-09-05	53	1
K894466	HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS	Hemotec, Inc.	1989-09-05	49	0
K884590	HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES	Hemotec, Inc.	1989-01-10	68	0
K875089	HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN	Hemotec, Inc.	1988-03-09	91	0
K880302	CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER	Hemotec, Inc.	1988-02-19	25	0
K854377	HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS	Hemotec, Inc.	1985-12-04	35	0
K854376	HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS	Hemotec, Inc.	1985-12-04	35	0
K853789	ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR	Hemotec, Inc.	1985-10-04	24	0
K843459	HEMOTEC ACT I SYSTEM	Hemotec, Inc.	1984-12-12	98	0
K841021	HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM	Hemotec, Inc.	1984-05-25	74	0
K830665	HEPCOL SYSTEM B-10 & B-10-P	Hemotec, Inc.	1983-06-08	97	0
K820410	HEMOTEC HEPCON/SYSTEM FOUR & FOUR P	Hemotec, Inc.	1982-04-09	56	0
K800161	HEPCON/SYSTEM RC-10	Hemotec, Inc.	1980-03-19	55	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