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

LFR · Predicate Candidate Screening

73 FDA 510(k) clearances under this product code; the 50 most recent screened below.

118 daysmedian FDA review time

307 days90th percentile

73clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K152328	FreeStyle InsuLinx Blood Glucose Monotioring System	Abott Laboratories	2015-09-17	30	0
K142089	ACCU-CHEK AVIVA EXPERT SYSTEM	Roche Diagnostics Corporation	2014-12-17	138	0
K133537	EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO M	Eps Bio Technology Corp.	2014-04-28	161	0
K131727	CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM	Ceragem Medisys, Inc.	2014-02-28	261	0
K131366	ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM	Roche Diagnostics Operations, Inc.	2013-10-11	151	0
K122688	NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR	Nova Biomedical Corporation	2013-04-04	212	0
K121433	GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (M	Hmd Biomedical, Inc.	2013-02-14	276	0
K122435	NOVA ONE BLOOD GLUCOSE MONITOR	Nova Biomedical Corporation	2012-12-20	132	0
K113314	PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING	Hmd Biomedical, Inc.	2012-11-09	366	0
K121224	GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM	Taidoc Technology Corporation	2012-09-19	152	0
K113307	GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM	Hmd Biomedical, Inc.	2012-07-27	262	0
K121190	CONTOUR NEXT BLOOD GLUCOSE METER	Bayer Healthcare, LLC	2012-07-26	98	0
K120042	TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD	Taidoc Technology Corporation	2012-05-22	138	0
K121207	EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU	Eps Bio Technology Corp.	2012-05-18	28	0
K113768	U-RIGHT TD-4280 BLOOD GLUCOSE MONITORING SYSTEM	Taidoc Technology Corporation	2012-04-12	113	0
K113243	EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM	Eps Bio Technology Corp.	2012-03-28	147	0
K110587	CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST	Bayer Healthcare, LLC	2012-03-28	393	0
K110894	CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER	Bayer Healthcare	2012-03-28	364	0
K111268	CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM	Bayer Healthcare	2012-03-06	307	1
K111874	FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS	Abbott Laboratories	2012-02-16	230	0
K112901	EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONIT	Eps Bio Technology Corp.	2011-12-23	81	0
K101299	ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM	Roche Diagnostics	2011-09-21	499	0
K110637	ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM	Cilag GmbH International	2011-09-07	187	1
K112272	EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MON	Eps Bio Technology Corp.	2011-09-07	30	0
K092688	FORA POCT S10/TD-4258 BLOOD GLUCOSE MONITORING SYSTEM	Taidoc Technology Corporation	2011-07-06	673	0
K101037	EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS100	Eps Bio Technology Corp.	2011-05-23	404	0
K083223	RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-	Abbott Diabetes Care, Inc.	2009-04-16	164	1
K070984	THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRI	Abbott Diabetes Care, Inc.	2007-11-01	209	3
K060765	HEMOCUE GLUCOSE 201 RT ANALYZER MDL 120731, HEMOCUE GLUCOSE	Hemocue AB	2006-09-06	169	0
K051592	MODIFICATION TO ACCU-CHEK GO SYSTEM	Roche Diagnostics Corp.	2005-09-02	79	0
K050872	ACCU-CHEK INTEGRA SYSTEM	Roche Diagnostics Corp.	2005-05-02	26	0
K043474	ACCU-CHEK AVIVA SYSTEM	Roche Diagnostics Corp.	2005-04-27	132	10
K041230	CLINICAL LABORATORY ANALYZING SYSTEM	Hemocue, Inc.	2004-05-20	10	1
K040796	ACCU-CHEK GO SYSTEM	Roche Diagnostics Corp.	2004-04-22	24	2
K032076	SENOVA(R) BLOOD GLUCOSE MONITOR	Chdiagnostics, LLC	2003-09-30	85	1
K031755	ACCU-CHEK COMPACT TEST STRIP	Roche Diagnostics Corp.	2003-07-03	27	0
K022941	MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR	Abbott Laboratories	2002-10-28	55	0
K021960	PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE M	Abbott Laboratories	2002-08-16	63	0
K004010	ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACC	Roche Diagnostics Corp.	2001-04-26	121	0
K003846	ACCU-CHEK INFORM METER	Roche Diagnostics Corp.	2001-03-19	97	2
K010362	ACCU-CHEK COMFORT CURVE TEST STRIP	Roche Diagnostics Corp.	2001-03-07	29	6
K000582	FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001	Abbott Diabetes Care, Inc.	2000-12-05	287	0
K001993	SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST S	Abbott Laboratories	2000-11-13	137	0
K994433	CONNECT DATA MANAGEMENT SYSTEM	Abbott Diabetes Care, Inc.	2000-05-05	127	1
K000364	ACCU-CHEK COMPLETE METER	Roche Diagnostics Corp.	2000-02-23	19	0
K992684	FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM	Abbott Diabetes Care, Inc.	2000-01-14	157	2
K993829	ACCU-CHEK SIMPLICITY SYSTEM	Roche Diagnostics Corp.	1999-12-09	27	0
K983047	ACCU-CHEK HQ SYSTEM	Boehringer Mannheim Corp.	1999-02-05	157	1
K982089	ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TE	Boehringer Mannheim Corp.	1998-09-03	80	7
K982002	ACCU-CHEK COMFORT CURVE TEST STRIP	Boehringer Mannheim Corp.	1998-09-02	86	1

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