Atlas FDA

CEM

89 FDA 510(k) clearances · Product code

66 daysmedian time to decision
195 days90th percentile
89clearances measured

FDA profile

Official device name
Electrode, Ion Specific, Potassium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1600
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 18 · 2022: 16 · 2023: 30 · 2024: 42 · 2025: 29 · 2026: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions (K253491)Roche Diagnostics2026-02-12
ABL90 FLEX PLUS System (K241037)Radiometer Medicals Aps2025-01-14
EasyStat 300 (K220396)Medica Corporation2023-09-26
ISE Electrodes (K230890)Randox Laboratories, Ltd.2023-09-08
SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ (K200544)Diamond Diagnostics, Inc.2020-10-01
FLEXLAB 3.6, ACCELERATOR A3600 (K121012)Inpeco S.P.A.2012-08-31
SMARTLYTE ELECTROLYTE ANALYZER (K121040)Diamond Diagnostics, Inc.2012-08-30
GEM PREMIER 4000 (K112995)Instrumentation Laboratory CO2012-05-03
BIOLIS 12I (K110520)Tokyo Boeki Medisys, Inc.2012-03-23
AU5800(R) CHEMISTRY ANALYZER (K112412)Beckman Coulter, Inc.2011-12-23
POLY-CHEM 90 ISE MODULE (K112408)Polymedco, Inc.2011-11-04
EASTLYTE NA/K/CA/PH (K112788)Medica Corp.2011-10-20
ABL90 FLEX SERIES (K092686)Radiometer Medical Aps2010-08-06
BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER (K092849)Epocal, Inc.2010-03-30
ACCELERATOR APS (K093318)Abbott Laboratories2010-02-19
VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258 (K083680)Ortho-Clinical Diagnostics, Inc.2009-02-27
VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2 (K073157)Ortho-Clinical Diagnostics, Inc.2007-12-07
DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 (K061107)Thermo Electron OY2006-08-08
OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 (K061730)Osmetech, Inc.2006-08-04
RX IMOLA (K052914)Randox Laboratories, Ltd.2006-03-31
COBAS 6000 SERIES SYSTEM (K060373)Roche Diagnostics2006-03-13
UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS (K042291)Beckman Coulter, Inc.2004-11-12
BIO-CHEM ANALYZER, MODEL 100 (K040750)Clinical Analysis Corporation, Inc.2004-10-28
STAT K IN VITRO DIAGNOSTIC TEST SYSTEM (K042270)Stat Chem, Inc.2004-10-06
ROCHE DIAGNOSTICS OMNI S ANALYZER (K032311)Roche Diagnostics Corp.2003-10-17
OMNI C ANALYZER (K013373)Roche Diagnostics Corp.2001-11-02
DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND (K010061)Dade Behring, Inc.2001-03-14
ALCYON 300I (WITH ISE MODULE) ANALYZER (K993083)Abbott Laboratories1999-10-05
AVL OPTI CRITICAL CARE ANALYZER (K974784)Avl Scientific Corp.1998-02-24
DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE (K970330)Dade Intl., Inc.1997-04-14
EASY STAT SODIUM/POTASSIUM/LITHIUM ANALYZER (K961326)Medica Corp.1996-06-21
EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+) (K961115)Johnson & Johnson Clinical Diagnostics, Inc.1996-05-07
DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD (K932044)Dupont Medical Products1993-07-27
NOVA NA/K/CL/LI MODULE (K922943)Nova Biomedical Corp.1992-10-13
MILES POTASSIUM METHOD (K923038)Heraeus Kulzer, Inc.1992-08-24
STAT K SYSTEM (K915345)Portable Diagnostic Services, Inc.1992-07-16
NOVA 11 NA/K/LI ANALYZER (K915178)Nova Biomedical Corp.1992-01-27
NOVA 5 NA/K/C1 ALALYZER (K915177)Nova Biomedical Corp.1992-01-27
ISE/K+ (K912649)Boehringer Mannheim Corp.1991-07-15
MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER (K900788)Datachem, Inc.1990-07-05
IONOMETER EH (K901039)Fresenius USA, Inc.1990-06-28
IONOMETER EH-HK AND ACCESSORIES (K901041)Fresenius USA, Inc.1990-06-18
LYTENING 2Z LYTENING SYSTEM 31 (K900300)Baxter Healthcare Corp1990-03-01
SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM (K897110)Medisense, Inc.1990-02-27
AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER (K896692)Baxter Healthcare Corp1990-01-02
TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD (K895664)Technicon Instruments Corp.1989-11-14
POTASSIUM AND SODIUM ELECTROLYTE ANALYZER (K890792)Ionetics, Inc.1989-05-03
MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY (K884769)Ciba Corning Diagnostics Corp.1989-01-17
VISION LYTE (TM) POTASSIUM (K884566)Abbott Laboratories1988-12-02
AVL MODEL 986 ELECTROLYTE ANALYZER (K883240)Avl Scientific Corp.1988-09-22
AVL MODEL 985 ELECTROLYTE ANALYZER (K870657)Avl Scientific Corp.1987-05-12
AMRESCO FLOW PAC POTASSIUM REAGENT SET, #1460 (K870033)American Research Products Co.1987-01-21
SKD ELECTROCHEMICAL SYSTEM (ECS) (K854723)Smithkline Diagnostics, Inc.1986-03-05
IRON (K854298)Boehringer Mannheim Corp.1985-11-12
ILEX PROMPT CLINICAL CHEMISTRY ANALYER (K853068)Ilex Corp.1985-10-31
ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER (K853531)American Dade1985-09-04
SERA-210 ELECTROLYTE ANALYZER (K853356)Horiba Instruments, Inc.1985-09-03
VISION POTASSIUM (K850950)Abbott Laboratories1985-08-12
CHEM PRO 1000 CHEMISTRY ANALYSIS (K851100)Sen Tech Medical Corp.1985-07-09
ELECTROLYTE ANALYZER (K851808)Ionetics, Inc.1985-06-25
ION 2 REAGENT KI (K851350)Hi Chem, Inc.1985-04-29
SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, & (K844955)Miles Laboratories, Inc.1985-03-19
MODIFY ELECTROLYTE ANALYZER MODEL SERA-210 (K844806)Horiba Instruments, Inc.1985-01-08
ULTRA LYTE POTASSIUM REAGENT KIT (K843454)Ultra Quest Diagnostics, Inc.1984-11-27
LYTETEK 1000 NA/K SODIUM/POTASSIUM ANALYZER (K844044)Medica Corp.1984-11-27
DACOS PLUS LYTES OPTION (K843239)Coulter Electronics, Inc.1984-10-17
DYNA-LYTE 2000 (K842786)Abbott Diagnostics1984-09-14
ION SELECTIVE ELECTRODES & REAGENT SYS (K843008)American Monitor Corp.1984-09-04
ESCHWEILER COMBI-ANALYSER MTA-500 (K840961)U.S. Science, Inc.1984-08-10
ULTRA LYTE ANALYZER I 100 (K842315)Ultra Quest Diagnostics, Inc.1984-08-02
SENTECH'S ULAB 1000 CLINICAL CHEM. (K841575)Sen Tech Medical Corp.1984-07-06
AMRESCO E2A REAGENT SET 0562 & 0626 (K840887)American Research Products Co.1984-04-18
ACID BASE LABORATORY ABL4 (K833696)Radiometer America, Inc.1984-01-18
QEA SODIUM/POTASSIUM ANALYZER (K833776)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-12-29
POTASSIUM ELECTRODE TIP ASSAMBLY-K- (K833159)Hi Chem, Inc.1983-11-25
QEA SODIUM/POTASSIUM ANALYZER (K832036)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-07-18
SERUM IRON DIAGNOSTIC TEST KITS (K830104)Sclavo, Inc.1983-01-28
UNIMETER 330K (K822441)Boehringer Mannheim Corp.1982-10-08
MODEL 1020 NA/K ANALYZER (K821822)Thermo Orion1982-07-02
SODIUM/POTASSIUM REAGENT KITS (K811310)Chem-Elec, Inc.1981-07-10
POSTASSIUM BUFFER SOL. & WASH SOLUTION (K802158)Panmed, Inc.1980-10-10
REAGENT FOR DETERM. POTASSIUM/IN HUMAN (K800692)Diagnostic Solutions, Inc.1980-05-28
KODAK EKTACHEM ELECTROLYTE ANALYZER (K800054)Eastman Kodak Company1980-02-05
DUPONT ACA ION SELECTIVE ELECTRODE (K800016)E.I. Dupont DE Nemours & Co., Inc.1980-01-21
SODIUM/POTASSIUM BUFFER SOLUTION (K791692)Hi Chem, Inc.1979-09-17
ANALYZER, SODIUM/POTASSIUM (K791175)Nova Biomedical Corp.1979-08-10
SERUM, POTASSIUM DETERMINATION OF (K790018)Fisher Scientific Co., LLC1979-02-01
POTASSIUM (K771837)Gamma Enterprises, Inc.1977-11-02
CENTRIA SEPARATION COLUMNS TYPE A (K771118)Clinical Diagnostics, Inc.1977-07-11

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