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

Apex BioTechnology Corp. — Predicate Candidate Screening

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

146 daysmedian FDA review time

413 days90th percentile

35clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K242209	UASure II Blood Uric Acid Monitoring System	Apex BioTechnology Corp.	2025-04-04	249	0
K222234	GlucoSure ADVANCE Link Blood Glucose Monitoring System	Apex BioTechnology Corp.	2022-12-21	148	0
K220421	BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Gl	Apex BioTechnology Corp.	2022-11-04	263	0
K212140	GlucoSure Link Blood Glucose Monitoring System	Apex BioTechnology Corp.	2022-08-25	413	0
K202534	MTM301 Blood Glucose and Ketone Monitoring System	Apex BioTechnology Corp.	2022-04-06	582	0
K213887	GAL-1A Plus Blood Glucose Monitoring System	Apex BioTechnology Corp.	2022-03-29	106	0
K201880	MultiSure GK Link Blood Glucose and Ketone Monitoring System	Apex BioTechnology Corp.	2021-10-15	465	0
K202885	GlucoSure HT Plus Blood Glucose Monitoring System	Apex BioTechnology Corp.	2021-09-15	352	0
K182593	KET-1 Blood Ketone Monitoring System	Apex BioTechnology Corp.	2018-12-18	89	0
K182992	BGM014 Blood Glucose Monitoring System	Apex BioTechnology Corp.	2018-11-28	30	0
K170267	BGM009 Plus Blood Glucose Monitoring System	Apex BioTechnology Corp.	2017-03-09	41	0
K161299	BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glu	Apex BioTechnology Corp.	2016-12-23	228	0
K150396	Autosure Voice II Blood Glucose Monitoring System, Autosure	Apex BioTechnology Corp.	2015-10-14	238	0
K142689	GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glu	Apex BioTechnology Corp.	2015-08-06	318	0
K143750	MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glu	Apex BioTechnology Corp.	2015-05-07	127	0
K141036	BGM009 BLOOD GLUCOSE MONITORING SYSTEM	Apex BioTechnology Corp.	2015-05-01	374	0
K131750	AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM	Apex BioTechnology Corp.	2014-03-06	265	0
K120649	AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM	Apex BioTechnology Corp.	2012-07-06	126	0
K120448	MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MO	Apex BioTechnology Corp.	2012-04-06	52	0
K113547	GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE	Apex BioTechnology Corp.	2012-03-28	118	0
K113208	GAL-1A BLOOD GLUCOSE MONITORING SYSTEM	Apex BioTechnology Corp.	2012-01-26	86	0
K113098	AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STR	Apex BioTechnology Corp.	2012-01-17	90	0
K102816	GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS	Apex BioTechnology Corp.	2011-09-15	352	0
K101204	MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP	Apex BioTechnology Corp.	2011-08-31	488	0
K102481	AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST ST	Apex BioTechnology Corp.	2011-04-28	241	0
K102037	AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST S	Apex BioTechnology Corp.	2010-08-13	25	0
K100747	CONTREX PLUS LOW CONTROL SOLUTION	Apex BioTechnology Corp.	2010-04-14	29	0
K090043	AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS9001	Apex BioTechnology Corp.	2009-04-09	92	0
K073648	GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS9000	Apex BioTechnology Corp.	2008-04-10	106	0
K073137	GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS900	Apex BioTechnology Corp.	2008-04-01	146	0
K070088	ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM	Apex BioTechnology Corp.	2007-02-16	38	0
K062799	GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM	Apex BioTechnology Corp.	2007-02-06	140	0
K011233	MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100	Apex BioTechnology Corp.	2001-05-18	25	1
K002621	GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM	Apex BioTechnology Corp.	2001-01-22	152	1
K002624	GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM	Apex BioTechnology Corp.	2001-01-22	152	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