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

Hemocue AB — Predicate Candidate Screening

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

129 daysmedian FDA review time

214 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K201217	HemoCue Hb 301 System	Hemocue AB	2020-08-04	90	0
K181751	HemoCue Hb 801 System	Hemocue AB	2019-02-01	214	0
K071652	HEMOCUE WBC SYSTEM	Hemocue AB	2007-10-25	129	0
K060765	HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE	Hemocue AB	2006-09-06	169	0
K061047	HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MOD	Hemocue AB	2006-06-08	55	0
K053253	HEMOCUE ALBUMIN 201 ANALYZING SYSTEM	Hemocue AB	2006-02-17	88	2

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