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

CHQ — Predicate Candidate Screening

10 FDA 510(k) clearances under this product code; the 50 most recent screened below.

86 daysmedian FDA review time

196 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K051969	TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (	Ibl GmbH	2005-10-03	75
K032199	ESA PLASMA FREE METANEPHRINE ANALYSIS KIT	Esa, Inc.	2004-01-30	196
K972167	PLASMA CATECHOLAMINE KIT	Bioanalytical Systems, Inc.	1997-08-04	56
K963938	MODEL 5500 CEAS	Esa, Inc.	1996-12-26	86
K952919	URINARY METANEPHRINE KIT	Bioanalytical Systems, Inc.	1995-09-06	72
K943099	URINARY CATECHOLAMINE KIT	Bioanalytical Systems, Inc.	1994-10-07	100
K931148	MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM	Esa, Inc.	1993-06-09	96
K894966	PLASMA CATECHOLAMINES BY HPLC	Bio-Rad	1989-10-25	79
K873371	URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC)	Bio-Rad	1988-01-05	137
K855214	CAT-3 CATECHOLAMINE ASSAY KIT	Whale Scientific, Inc.	1986-03-14	74

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