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

Esa, Inc. — Predicate Candidate Screening

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

96 daysmedian FDA review time

196 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K032199	ESA PLASMA FREE METANEPHRINE ANALYSIS KIT	Esa, Inc.	2004-01-30	196	0
K971640	LEADCARE BLOOD LEAD TESTING SYSTEM	Esa, Inc.	1997-09-09	130	2
K963938	MODEL 5500 CEAS	Esa, Inc.	1996-12-26	86	0
K934977	MODEL 5500 CEAS	Esa, Inc.	1994-01-11	84	0
K931148	MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM	Esa, Inc.	1993-06-09	96	0
K903231	COULOCHEM II	Esa, Inc.	1990-09-27	66	0
K864729	NEUROCHEMICAL ANALYZER	Esa, Inc.	1987-04-13	130	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