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

JGS — Predicate Candidate Screening

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

64 daysmedian FDA review time

191 days90th percentile

162clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K252475	ABL90 FLEX PLUS System	Radiometer Medicals Aps	2026-05-01	267	0
K230275	i-STAT CG8+ cartridge with the i-STAT 1 System	Abbott Point of Care, Inc.	2023-10-27	268	0
K222438	A-LYTE® Integrated Multisensor (IMT Na K Cl)	Siemens Healthcare Diagnostics, Inc.	2023-07-25	347	0
K220977	ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemis	Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.	2023-07-20	472	5
K213486	GLP systems Track	Abbott Laboratories	2022-03-10	132	0
K200403	Stat Profile Prime Plus Analyzer System	Nova Biomedical Corporation	2020-04-14	55	2
K183688	i-STAT CHEM8+ cartridge with the i-STAT 1 System	Abbott Point of Care, Inc.	2020-02-07	406	0
K191365	Stat Profile Prime ES Comp Plus Analyzer System	Nova Biomedical Corporation	2019-07-19	58	0
K172232	LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creati	Ams Diagnostics	2019-06-12	687	0
K183549	GEM Premier ChemSTAT	Instrumentation Laboratory CO	2019-02-16	58	0
K180428	Stat Profile Prime Plus Analyzer System	Nova Biomedical Corporation	2018-08-15	180	0
K181201	Synermed ISE Reagents	Infrared Laboratory Systems, LLC (Dba Synermed)	2018-07-10	64	0
K171476	SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)	Awareness Technology, Inc.	2018-02-27	284	0
K161954	Atellica Solution, Atellica A-LYTE Integrated Multisensor Na	Siemens Healthcare Diagnostics	2017-03-09	234	2
K161837	ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemist	Beckman Coulter, Inc.	2016-12-16	164	0
K160225	GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chl	Instrumentation Laboratory CO	2016-12-14	320	0
K153357	i-STAT Alinity System with i-STAT Sodium test	Abbott Point of Care, Inc.	2016-07-08	231	0
K160370	BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer,	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2016-06-09	120	0
K151767	Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, C	Siemens Healthcare Diagnostics, Inc.	2015-12-11	164	2
K140373	ISE INDIRECT NA, K, C1 FOR GEN 2	Roche Diagnostics	2014-05-22	97	0
K132418	COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2	Roche Diagnostics	2013-12-18	138	0
K123726	COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2	Roche Diagnostics	2013-05-21	168	0
K121140	PROLYTE ELECTROLYTE ANALYZER	Diamond Diagnostics, Inc.	2012-08-22	128	0
K102647	ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AN	Elitechgroup Vital Scientific BV	2011-03-24	191	1
K102959	PROLYTE ELECTROLYTE ANALYZER	Diamond Diagnostics, Inc.	2011-01-14	101	0
K100829	EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE	Medica Corp.	2011-01-14	296	0
K100673	EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020	Medica Corp.	2010-04-06	28	0
K091861	VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND	Ortho-Clinical Diagnostics, Inc.	2009-09-03	76	0
K082462	GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+	Diamond Diagnostics, Inc.	2009-02-06	163	0
K081411	VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUC	Ortho-Clinical Diagnostics, Inc.	2008-06-30	41	2
K070104	PROLYTE ELECTROLYTE ANALYZER	Diamond Diagnostics, Inc.	2008-05-07	483	0
K061597	EPOC BLOOD ANALYSIS SYSTEM	Epocal, Inc.	2006-09-27	111	2
K053110	Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abb	I-Stat Corporation	2006-01-13	70	3
K053165	ISE INDIRECT NA, K, CL FOR GEN.2	Roche Diagnostics Corp.	2005-12-14	30	0
K052724	TECO ISE REAGENT SET FOR CX SYSTEM	Teco Diagnostics	2005-12-14	76	0
K051646	ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LO	Pointe Scientific, Inc.,	2005-10-07	108	0
K040977	GENCHEM ELECTROLYTE BUFFER	Genchem, Inc.	2004-12-27	257	0
K040971	GENCHEM ISE ELECTROLYTE REFERENCE	Genchem, Inc.	2004-12-22	252	0
K023049	SYNCHRON LX I 725 CLINICAL SYSTEM	Beckman Coulter, Inc.	2002-10-04	22	18
K020364	PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS	Phoenix Diagnostics, Inc.	2002-06-04	120	0
K011213	MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM	Beckman Coulter, Inc.	2001-05-16	26	11
K002407	EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZE	Medica Corp.	2001-02-02	179	0
K002855	BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER	Biocare Corp.	2000-10-12	29	0
K001761	STATLYTE NA/K/CL/LI ANALYZER	Nova Biomedical Corp.	2000-08-07	59	0
K001154	I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER	I-Stat Corp.	2000-04-18	8	4
K000895	STAT PROFILE PHOX PLUS ANALYZER	Nova Biomedical Corp.	2000-04-17	28	0
K992842	HICHEM ISE ELECTROLYTE REFERENCE	Elan Holdings, Inc.	1999-11-26	94	0
K992844	HICHEM ISE ELECTROLYTE BUFFER	Elan Holdings, Inc.	1999-11-26	94	0
K993211	PICCOLO SODIUM TEST SYSTEM	Abaxis, Inc.	1999-10-25	31	0
K990346	BAYER ADVIA 1650 CHEMISTRY SYSTEM	Bayer Corp.	1999-05-21	106	12

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