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

JFL — Predicate Candidate Screening

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

60 daysmedian FDA review time

158 days90th percentile

28clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K191298	i-STAT CHEM8+ cartridge with the i-STAT 1 System	Abbott Point of Care, Inc.	2020-02-07	269	0
K040975	GENCHEM CO2 ACID REAGENT	Genchem, Inc.	2004-12-27	257	0
K014034	MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20	Beckman Coulter, Inc.	2001-12-18	11	4
K963541	SIGMA DIAGNOSTICS CO2 ACID REAGENT	Sigma Diagnostics, Inc.	1996-10-24	50	0
K963538	SIGMA DIAGNOSTICS CO2ALKALINE BUFFER	Sigma Diagnostics, Inc.	1996-10-11	37	0
K963540	SIGMA DIAGNOSTICS ELECTROLYTE BUFFER	Sigma Diagnostics, Inc.	1996-09-27	23	0
K963005	NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)	Nova Biomedical Corp.	1996-08-23	21	0
K933696	SIGMA ELECTROLYTE REFERENCE REAGENT	Sigma Chemical Co.	1994-01-03	158	0
K933691	SIGMA CO2 ALKALINE BUFFER REAGENT	Sigma Chemical Co.	1993-12-17	141	0
K933692	SIGMA CO2 ACID REAGENT	Sigma Chemical Co.	1993-12-09	133	0
K933695	SIGMA ELECTROLYTE BUFFER	Sigma Chemical Co.	1993-10-22	85	0
K925553	HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813	Hichem Diagnostics	1993-02-12	101	0
K925552	HI CHEM CO2 ACID REAGENT KIT,PRODUCT NUMBER 88812	Hichem Diagnostics	1993-02-12	101	0
K900185	NIIC MODEL: DX901 ASPIRATION SYSTEM	Niic U.S.A., Inc.	1990-05-24	128	0
K897183	SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS	Beckman Instruments, Inc.	1990-03-30	92	0
K900420	BICARBONATE REAGENTS PRODUCT #7713 & #7714	American Research Products Co.	1990-03-01	30	0
K873129	CARBON DIOXIDE REAGENT KIT	A-Kem, Inc.	1987-10-23	74	0
K842656	REPLACEMENT PARTS NOVA ELECTROLYTE ANAL	Shaban Mfg. Co.	1984-08-12	33	0
K822117	FERMCOTEST CO2 REAGNET	Fermco Biochemics, Inc.	1982-09-30	73	0
K820388	LIQUIZYME CO2REAGENT SET	American Research Products Co.	1982-03-08	26	0
K811381	ASTRA	Chem-Elec, Inc.	1981-08-13	90	0
K802035	BAKER DIAG. ULTRARATE CO2 REAGENT KIT	J.T. Baker Chemical Co.	1980-09-26	35	0
K800586	NSI CARBON DIOXIDE REAGENT KIT	Nobel Scientific Industries, Inc.	1980-04-04	18	0
K800218	CARBON DIOXIDE CUP REAGENT & REF.RGT.	Fisher Scientific Co., LLC	1980-02-26	22	0
K792254	NOVA 3+3 CHLORIDE/TOTAL CARBON DIOXIDE	Nova Biomedical Corp.	1979-12-06	28	0
K791687	CO2 REFERENCE REAGENT	Hi Chem, Inc.	1979-09-17	48	0
K791686	CO2 CUP REAGENT	Hi Chem, Inc.	1979-09-17	48	0
K771592	STAT/LYTE ANALYZER	Technicon Instruments Corp.	1977-10-18	60	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