FDA product code CEM: Electrode, Ion Specific, Potassium
CEM is the FDA product code for electrode, ion specific, potassium. It is a Class II device, regulated under 21 CFR 862.1600 and reviewed by the Clinical Chemistry panel. FDA has cleared 89 510(k) submissions under CEM, 4 in the last five years, from 61 different applicants. The average 510(k) review took 90 days (median 66); 192 days on average over the last three years. FDA has posted 63 recalls for CEM devices, 12 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Ion Specific, Potassium |
| Device class | Class II |
| Regulation | 21 CFR 862.1600 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CEM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 212 |
| 2023 | 2 | 376 |
| 2025 | 1 | 273 |
| 2026 | 1 | 111 |
Compare with all 510(k) review times · Search every CEM clearance
Top CEM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 4 | 2010-02-19 |
| Nova Biomedical Corp. | 4 | 1992-10-13 |
| Medica Corp. | 3 | 2011-10-20 |
| Avl Scientific Corp. | 3 | 1998-02-24 |
| Boehringer Mannheim Corp. | 3 | 1991-07-15 |
56 more applicants have CEM clearances. See the full list in Caduvo.
Most recent CEM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253491 | Roche Diagnostics | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions | 2026-02-12 | 111 |
| K241037 | Radiometer Medicals Aps | ABL90 FLEX PLUS System | 2025-01-14 | 273 |
| K220396 | Medica Corporation | EasyStat 300 | 2023-09-26 | 592 |
| K230890 | Randox Laboratories, Ltd. | ISE Electrodes | 2023-09-08 | 161 |
| K200544 | Diamond Diagnostics, Inc. | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ | 2020-10-01 | 212 |
Recalls for CEM devices
63 product recalls in 35 recall events; 12 initiated in the last five years and 18 still open. Most recent: 2025-12-31.
| Year | Recalls |
|---|---|
| 2018 | 4 |
| 2019 | 2 |
| 2020 | 14 |
| 2021 | 4 |
| 2023 | 7 |
| 2025 | 5 |
Frequently asked questions
What is FDA product code CEM?
CEM is the FDA product code for electrode, ion specific, potassium. It is a Class II device, regulated under 21 CFR 862.1600 and reviewed by the Clinical Chemistry panel.
What device class is CEM?
Class II, regulation 21 CFR 862.1600. Typical premarket route: 510(k).
How long does a 510(k) take for product code CEM?
Across 89 cleared submissions the average was 90 days from receipt to decision (median 66).
Which companies have the most CEM clearances?
Abbott Laboratories (4); Nova Biomedical Corp. (4); Medica Corp. (3); Avl Scientific Corp. (3); Boehringer Mannheim Corp. (3).
Have CEM devices been recalled?
Yes: 63 product recalls across 35 recall events; the most recent began 2025-12-31.
Next steps
- Run an FDA pathway report with predicate devices for product code CEM
- Run a recall and safety report across every CEM manufacturer
- Watch product code CEM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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