Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

JJE — Predicate Candidate Screening

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

54 daysmedian FDA review time

138 days90th percentile

208clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K183375	Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, P	Horiba, Ltd.	2019-02-12	68	0
K133519	CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAR	Carolina Liquid Chemistries Corp.	2014-05-16	182	0
K130915	XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE	Jas Diagnostics, Inc.	2014-05-15	408	0
K131554	RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTAT	Randox Laboratories, Ltd.	2014-01-09	224	2
K130276	DIMENSION EXL WITH LM SYSTEM	Siemens Healthcare Diagnostics, Inc.	2013-03-22	45	5
K113253	ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE	Alfa Wassermann Diagnostic Technologies, Inc.	2012-05-17	197	0
K112999	DIMENSION CLINICAL CHEMISTRY SYSTEM	Siemens Healthcare Diagnostics	2011-11-22	46	5
K110035	INDIKO	Thermofisher Scientific OY	2011-06-28	174	0
K073370	TC MATRIX CLINICAL CHEMISTRY ANALYZER	Teco Diagnostics	2008-05-08	160	0
K063144	VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMAT	Ortho-Clinical Diagnostics, Inc.	2006-11-13	28	24
K051087	DIMENSION VISTA INTEGRATED SYSTEM	Dade Behring, Inc.	2005-07-11	74	27
K042169	STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER	Stanbio Laboratory	2005-03-14	215	0
K040958	PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240	Tokyo Boeki Medical System , Ltd.	2005-02-15	308	0
K023764	UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100	Beckman Coulter, Inc.	2003-01-28	77	30
K010500	AUTOMATED WORKCELL CONTROL SOFTWARE	Lab-Interlink, Inc.	2001-08-01	161	0
K003721	MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER	Olympus America, Inc.	2000-12-18	14	4
K002982	OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER	Olympus America, Inc.	2000-10-25	30	0
K983345	BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY	Bayer Corp.	1998-12-07	75	0
K974779	ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH IS	Abbott Laboratories	1998-02-13	53	0
K974651	ABBOTT AXSYM SYSTEM	Abbott Laboratories	1998-02-12	66	5
K971761	PERSONALLAB AUTOMATED MICROPLATE ANALYZER	Biochem Immunosystems (U.S.), Inc.	1997-07-22	71	0
K970227	IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER	Dpc Cirrus	1997-04-08	81	11
K965240	SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMI	Beckman Instruments, Inc.	1997-03-10	70	12
K961142	STRATEC LIA II ANALYZER	Nichols Institute Diagnostics	1997-02-18	334	0
K963539	SIGMA DIAGNOSTICS WASH CONCENTRATE	Sigma Diagnostics, Inc.	1996-12-16	103	0
K962231	COBAS CORE IMMUNOCHEMISTRY SYSTEM	Roche Diagnostic Systems, Inc.	1996-08-30	81	0
K962125	TECHNICON IMMUNO 1 SYSTEM	Bayer Corp.	1996-08-02	60	0
K961274	OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER	Olympus America, Inc.	1996-07-05	94	7
K962235	VITROS SPECIALTY DILUENT	Johnson & Johnson Clinical Diagnostics, Inc.	1996-06-26	15	2
K961481	ELECSYS 2010 ANALYZER	Boehringer Mannheim Corp.	1996-06-14	57	4
K953239	BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER	Boehringer Mannheim Corp.	1995-09-25	76	16
K942922	SELECTA 20/60 CHEMISTRY ANALYZER	Select Medical Systems, Inc.	1995-07-19	393	0
K951189	SYNCHRON CX4CE/CX5CE/CX7 CLINICAL SYSTEMS SOFTWARE UPDATE VE	Beckman Instruments, Inc.	1995-06-13	89	1
K945566	ABBOTT PROJECT I, SPECTRUM	Abbott Laboratories	1995-06-09	231	0
K950915	ABBOTT AXSYM II SYSTEM	Abbott Laboratories	1995-05-16	76	0
K950958	SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA)	Beckman Instruments, Inc.	1995-05-08	82	4
K950353	TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM	Miles, Inc.	1995-04-20	80	0
K945271	ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM	Bio-Chem Laboratory Systems, Inc.	1995-04-20	184	0
K945135	MICROPLATE PROCESSOR 3000	Organon Teknika Corp.	1995-03-03	134	0
K943493	DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER	Hamilton Co.	1995-01-30	195	1
K946090	KODAK EKTACCHEM 950IRC ANALYZER	Clinical Diagnostic Systems, Inc.	1995-01-17	35	1
K944028	PROCHEM CHEMISTRY ANALYZER	Prisma Systems	1994-11-30	105	0
K944093	DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM	E.I. Dupont DE Nemours & Co., Inc.	1994-11-10	80	0
K942364	HITACHI 914 ANALYZER	Boehringer Mannheim Corp.	1994-10-04	140	0
K942443	AURAFLEX SYSTEMS	Organon Teknika Corp.	1994-08-26	95	0
K940289	ABBOTT PRISM ANALYZER	Abbott Mfg., Inc.	1994-07-18	138	0
K940810	CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF	Ciba Corning Diagnostics Corp.	1994-05-23	90	0
K933703	SIGMA WASH CONCENTRATE SOLUTION	Sigma Chemical Co.	1993-12-10	134	0
K933548	ELS 1000	Bio-Tek Instruments, Inc.	1993-10-29	101	0
K931786	ACE CLINICAL CHEMISTRY SYSTEM	Schiapparelli Biosystems, Inc.	1993-09-21	165	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