CEM · Class II · 21 CFR 862.1600

FDA Product Code CEM: Electrode, Ion Specific, Potassium

Leading manufacturers include Abbott Laboratories, Nova Biomedical Corp. and Medica Corp..

89
Total
89
Cleared
90d
Avg days
1977
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg 192d recently vs 88d historically

FDA 510(k) Cleared Electrode, Ion Specific, Potassium Devices (Product Code CEM)

89 devices
1–24 of 89
Cleared Feb 12, 2026
ISE indirect K for Gen.2
K253491
Roche Diagnostics
Chemistry · 111d
Cleared Jan 14, 2025
ABL90 FLEX PLUS System
K241037
Radiometer Medicals Aps
Chemistry · 273d
Cleared Sep 26, 2023
EasyStat 300
K220396
Medica Corporation
Chemistry · 592d
Cleared Sep 08, 2023
ISE Electrodes
K230890
Randox Laboratories, Ltd.
Chemistry · 161d
Cleared Oct 01, 2020
SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
K200544
Diamond Diagnostics, Inc.
Chemistry · 212d
Cleared Aug 31, 2012
FLEXLAB 3.6, ACCELERATOR A3600
K121012
Inpeco S.P.A.
Chemistry · 150d
Cleared Aug 30, 2012
SMARTLYTE ELECTROLYTE ANALYZER
K121040
Diamond Diagnostics, Inc.
Chemistry · 147d
Cleared May 03, 2012
GEM PREMIER 4000
K112995
Instrumentation Laboratory CO
Chemistry · 209d
Cleared Mar 23, 2012
BIOLIS 12I
K110520
Tokyo Boeki Medisys, Inc.
Chemistry · 394d
Cleared Dec 23, 2011
AU5800(R) CHEMISTRY ANALYZER
K112412
Beckman Coulter, Inc.
Chemistry · 123d
Cleared Nov 04, 2011
POLY-CHEM 90 ISE MODULE
K112408
Polymedco, Inc.
Chemistry · 74d
Cleared Oct 20, 2011
EASTLYTE NA/K/CA/PH
K112788
Medica Corp.
Chemistry · 24d
Cleared Aug 06, 2010
ABL90 FLEX SERIES
K092686
Radiometer Medical Aps
Chemistry · 338d
Cleared Mar 30, 2010
BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER
K092849
Epocal, Inc.
Chemistry · 195d
Cleared Feb 19, 2010
ACCELERATOR APS
K093318
Abbott Laboratories
Chemistry · 119d
Cleared Feb 27, 2009
VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258
K083680
Ortho-Clinical Diagnostics, Inc.
Chemistry · 77d
Cleared Dec 07, 2007
VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2
K073157
Ortho-Clinical Diagnostics, Inc.
Chemistry · 29d
Cleared Aug 08, 2006
DPC T60I KUSTI, MODEL 984248
K061107
Thermo Electron OY
Chemistry · 110d
Cleared Aug 04, 2006
OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044
K061730
Osmetech, Inc.
Chemistry · 45d
Cleared Mar 31, 2006
RX IMOLA
K052914
Randox Laboratories, Ltd.
Chemistry · 168d
Cleared Mar 13, 2006
COBAS 6000 SERIES SYSTEM
K060373
Roche Diagnostics
Immunology · 28d
Cleared Nov 12, 2004
UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS
K042291
Beckman Coulter, Inc.
Chemistry · 80d
Cleared Oct 28, 2004
BIO-CHEM ANALYZER, MODEL 100
K040750
Clinical Analysis Corporation, Inc.
Chemistry · 219d
Cleared Oct 06, 2004
STAT K IN VITRO DIAGNOSTIC TEST SYSTEM
K042270
Stat Chem, Inc.
Chemistry · 44d

About Product Code CEM - Regulatory Context

510(k) Submission Activity

89 total 510(k) submissions under product code CEM since 1977, with 89 receiving FDA clearance (average review time: 90 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - CEM Product Code

Recent submissions under CEM have taken an average of 192 days to reach a decision - up from 88 days historically. Manufacturers should account for longer review timelines in current project planning.

CEM devices are reviewed by the Chemistry panel. Browse all Chemistry devices →