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

CellaVision AB — Predicate Candidate Screening

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

146 daysmedian FDA review time

357 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K200595	CellaVision DC-1, CellaVision DC-1 PPA	CellaVision AB	2020-10-16	224	0
K171315	Advanced RBC Application	CellaVision AB	2017-08-01	89	0
K102778	CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION	CellaVision AB	2011-09-16	357	0
K092868	CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-1	CellaVision AB	2009-11-20	63	1
K080595	CELLAVISION DM96 WITH THE BODY FLUID APPLICATION	CellaVision AB	2008-12-05	277	0
K033840	CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER	CellaVision AB	2004-02-10	62	0
K003301	DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER	CellaVision AB	2001-03-15	146	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