CEM · Class II · 21 CFR 862.1600

FDA Product Code CEM: Electrode, Ion Specific, Potassium

Leading manufacturers include Abbott Laboratories, Boehringer Mannheim Corp. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

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 May 03, 2012
GEM PREMIER 4000
K112995
Instrumentation Laboratory CO
Chemistry · 209d
Cleared Dec 23, 2011
AU5800(R) CHEMISTRY ANALYZER
K112412
Beckman Coulter, Inc.
Chemistry · 123d
Cleared Feb 19, 2010
ACCELERATOR APS
K093318
Abbott Laboratories
Chemistry · 119d
Cleared Nov 12, 2004
UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS
K042291
Beckman Coulter, Inc.
Chemistry · 80d
Cleared Oct 17, 2003
ROCHE DIAGNOSTICS OMNI S ANALYZER
K032311
Roche Diagnostics Corp.
Chemistry · 81d
Cleared Nov 02, 2001
OMNI C ANALYZER
K013373
Roche Diagnostics Corp.
Chemistry · 22d
Cleared Mar 14, 2001
DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND
K010061
Dade Behring, Inc.
Chemistry · 65d
Cleared Oct 05, 1999
ALCYON 300I (WITH ISE MODULE) ANALYZER
K993083
Abbott Laboratories
Chemistry · 20d
Cleared Jul 15, 1991
ISE/K+
K912649
Boehringer Mannheim Corp.
Chemistry · 28d
Cleared Mar 01, 1990
LYTENING 2Z LYTENING SYSTEM 31
K900300
Baxter Healthcare Corp
Chemistry · 38d
Cleared Jan 02, 1990
AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER
K896692
Baxter Healthcare Corp
Chemistry · 35d
Cleared Dec 02, 1988
VISION LYTE (TM) POTASSIUM
K884566
Abbott Laboratories
Chemistry · 31d
Cleared Nov 12, 1985
IRON
K854298
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared Aug 12, 1985
VISION POTASSIUM
K850950
Abbott Laboratories
Chemistry · 158d
Cleared Dec 29, 1983
QEA SODIUM/POTASSIUM ANALYZER
K833776
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 63d
Cleared Jul 18, 1983
QEA SODIUM/POTASSIUM ANALYZER
K832036
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 24d
Cleared Oct 08, 1982
UNIMETER 330K
K822441
Boehringer Mannheim Corp.
Chemistry · 53d
Cleared Feb 05, 1980
KODAK EKTACHEM ELECTROLYTE ANALYZER
K800054
Eastman Kodak Company
Chemistry · 27d
Cleared Jan 21, 1980
DUPONT ACA ION SELECTIVE ELECTRODE
K800016
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 14d

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 →