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

Eps Bio Technology Corp. — Predicate Candidate Screening

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

95 daysmedian FDA review time

333 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K201258	EASYMAX Tag Self-Monitoring Blood Glucose System	Eps Bio Technology Corp.	2021-09-01	478	0
K190189	MDT2 BLE Self-Monitoring Blood Glucose System	Eps Bio Technology Corp.	2019-11-01	273	0
K182057	EasyMax BT Self-Monitoring Blood Glucose System	Eps Bio Technology Corp.	2018-08-24	24	0
K133537	EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO M	Eps Bio Technology Corp.	2014-04-28	161	0
K133389	EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM	Eps Bio Technology Corp.	2014-04-15	161	0
K133647	EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING B	Eps Bio Technology Corp.	2014-02-27	92	0
K121207	EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU	Eps Bio Technology Corp.	2012-05-18	28	0
K113243	EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM	Eps Bio Technology Corp.	2012-03-28	147	0
K112901	EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONIT	Eps Bio Technology Corp.	2011-12-23	81	0
K111728	EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MON	Eps Bio Technology Corp.	2011-09-16	88	0
K112272	EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MON	Eps Bio Technology Corp.	2011-09-07	30	0
K102345	EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10	Eps Bio Technology Corp.	2011-06-21	306	0
K101037	EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS100	Eps Bio Technology Corp.	2011-05-23	404	0
K101457	EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL	Eps Bio Technology Corp.	2010-07-01	36	0
K092894	EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM	Eps Bio Technology Corp.	2010-02-24	156	0
K092887	EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYS	Eps Bio Technology Corp.	2009-10-21	30	0
K091481	EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM	Eps Bio Technology Corp.	2009-08-18	91	0
K091229	GLUCOMANAGER DATA MANAGEMENT SOFTWARE	Eps Bio Technology Corp.	2009-07-31	95	0
K081796	EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEM	Eps Bio Technology Corp.	2009-01-23	212	0
K083099	EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08	Eps Bio Technology Corp.	2009-01-16	88	1
K082121	EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS0800	Eps Bio Technology Corp.	2008-09-17	51	0
K070053	EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1	Eps Bio Technology Corp.	2007-12-03	333	0
K061992	EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014	Eps Bio Technology Corp.	2006-09-19	68	0
K043245	EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM	Eps Bio Technology Corp.	2005-04-29	157	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