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

Epocal, Inc. — Predicate Candidate Screening

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

195 daysmedian FDA review time

291 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K200107	epoc Blood Analysis System	Epocal, Inc.	2020-06-05	140	18
K171247	epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Tes	Epocal, Inc.	2018-01-17	264	0
K113726	EPOC CHLORIDE TEST AND EPOC CREATININE TEST	Epocal, Inc.	2012-10-05	291	0
K093297	EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY	Epocal, Inc.	2010-06-09	231	1
K092849	BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLO	Epocal, Inc.	2010-03-30	195	0
K090109	BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD	Epocal, Inc.	2009-06-24	160	3
K061597	EPOC BLOOD ANALYSIS SYSTEM	Epocal, Inc.	2006-09-27	111	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