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

Hemocue, Inc. — Predicate Candidate Screening

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

55 daysmedian FDA review time

186 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K041234	HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM	Hemocue, Inc.	2004-06-10	31	1
K041230	CLINICAL LABORATORY ANALYZING SYSTEM	Hemocue, Inc.	2004-05-20	10	1
K032203	HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704	Hemocue, Inc.	2003-08-25	38	1
K020935	HEMOCUE GLUCOSE 201 SYSTEM, ARTICLE NUMBER 120706	Hemocue, Inc.	2002-04-03	12	4
K962415	HEMOCUE B-GLCOSE SYSTEM	Hemocue, Inc.	1996-10-15	125	0
K961312	HEMOCUE B-HEMOGLOBIN SYSTEM	Hemocue, Inc.	1996-09-24	173	0
K961311	HEMOCUE B-GLUCOSE SYSTEM	Hemocue, Inc.	1996-08-23	141	0
K943432	HEMOCUE B-GLUCOSE SYSTEM	Hemocue, Inc.	1995-01-17	186	0
K911141	HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER	Hemocue, Inc.	1991-05-08	55	1

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