FDA product code NCG: Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
NCG is the FDA product code for neuropsychiatric interpretative electroencephalograph assessment aid. It is a Class II device, regulated under 21 CFR 882.1440 and reviewed by the Neurology panel. FDA has cleared 2 510(k) submissions under NCG, 2 in the last five years, from 2 different applicants. The average 510(k) review took 158 days (median 158); 167 days on average over the last three years. 1 De Novo request was granted under it.
Definition
Uses a patient's electroencephalograph (EEG) to provide an interpretation of the patient's neuropsychiatric condition. It is also used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis."
Classification
| Field | Value |
|---|---|
| Device name | Neuropsychiatric Interpretative Electroencephalograph Assessment Aid |
| Device class | Class II |
| Regulation | 21 CFR 882.1440 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for NCG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 149 |
| 2025 | 1 | 167 |
Compare with all 510(k) review times · Search every NCG clearance
Top NCG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ceribell, Inc. | 1 | 2025-12-08 |
| Prolira B.V. | 1 | 2023-02-02 |
Most recent NCG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251936 | Ceribell, Inc. | Ceribell Delirium Monitor System | 2025-12-08 | 167 |
| K222680 | Prolira B.V. | DeltaScan Monitor | 2023-02-02 | 149 |
Recalls for NCG devices
openFDA lists no recalls for product code NCG.
Frequently asked questions
What is FDA product code NCG?
NCG is the FDA product code for neuropsychiatric interpretative electroencephalograph assessment aid. It is a Class II device, regulated under 21 CFR 882.1440 and reviewed by the Neurology panel.
What device class is NCG?
Class II, regulation 21 CFR 882.1440. Typical premarket route: 510(k).
How long does a 510(k) take for product code NCG?
Across 2 cleared submissions the average was 158 days from receipt to decision (median 158).
Which companies have the most NCG clearances?
Ceribell, Inc. (1); Prolira B.V. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NCG
- Run a recall and safety report across every NCG manufacturer
- Watch product code NCG 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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