Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Beckman Coulter Ireland, Inc. · Predicate Candidate Screening

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

54 daysmedian FDA review time

222 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K182651	HbA1c Advanced	Beckman Coulter Ireland, Inc.	2019-01-16	114	0
K161508	Ceruloplasmin	Beckman Coulter Ireland, Inc.	2017-01-09	222	0
K161297	Beta-2-Microglobulin	Beckman Coulter Ireland, Inc.	2016-06-07	29	0
K142346	Urine/CSF Albumin, Urine/CSF Albumin Calibrator	Beckman Coulter Ireland, Inc.	2014-10-15	54	0
K141388	SYSTEM CALIBRATER	Beckman Coulter Ireland, Inc.	2014-07-11	45	0
K141374	BICARBONATE CALIBRATOR	Beckman Coulter Ireland, Inc.	2014-06-30	34	0
K131546	AU BICARBONATE REAGENT	Beckman Coulter Ireland, Inc.	2013-10-09	133	4

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