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

Infopia Co, Ltd. — Predicate Candidate Screening

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

198 daysmedian FDA review time

400 days90th percentile

20clearances measured

K-number	Device	Applicant	Decided	Review days
K160365	BLE Smart Blood Glucose Monitoring System, BLE Smart Profess	Infopia Co, Ltd.	2016-09-28	232
K150274	GDH Professional Blood Glucose Monitoring System and GDH Pro	Infopia Co, Ltd.	2015-08-26	203
K141750	HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM	Infopia Co, Ltd.	2014-07-24	24
K132406	ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM	Infopia Co, Ltd.	2014-04-18	259
K133045	ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM	Infopia Co, Ltd.	2014-04-10	195
K132862	HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM	Infopia Co, Ltd.	2013-12-12	91
K132966	GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIO	Infopia Co, Ltd.	2013-12-05	76
K130181	GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLO	Infopia Co, Ltd.	2013-07-31	187
K130295	LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPR	Infopia Co, Ltd.	2013-06-21	135
K121366	HEMOCUE HBA1C 501	Infopia Co, Ltd.	2012-09-07	123
K113192	HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM	Infopia Co, Ltd.	2012-07-13	256
K113670	ELEMENT BLOOD GLUCOSE MONITORING SYSTEM	Infopia Co, Ltd.	2012-05-08	147
K103021	ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM	Infopia Co, Ltd.	2011-11-04	388
K091168	GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025	Infopia Co, Ltd.	2010-05-27	400
K082275	CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE M	Infopia Co, Ltd.	2010-01-14	521
K090405	LIPIDPRO SYSTEM	Infopia Co, Ltd.	2009-12-01	285
K091157	GLUCO LAB AUTO CODING, MODEL IGM-0022	Infopia Co, Ltd.	2009-11-17	210
K090712	EOCENE SYSTEM	Infopia Co, Ltd.	2009-10-02	198
K082020	ENVISION BLOOD GLUCOSE TEST SYSTEM	Infopia Co, Ltd.	2008-12-24	161
K051285	GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM	Infopia Co, Ltd.	2005-08-02	77

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