FDA product code PIW: Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
PIW is the FDA product code for brain injury adjunctive interpretive electroencephalograph assessment aid. It is a Class II device, regulated under 21 CFR 882.1450 and reviewed by the Neurology panel. FDA has cleared 8 510(k) submissions under PIW, 2 in the last five years, from 2 different applicants. The average 510(k) review took 134 days (median 152); 143 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A prescription device that uses a patient¿s electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient¿s brain in the setting of trauma. The Brain Injury Adjunctive Interpretive EEG Assessment Aid is for use as an adjunct to standard clinical practice only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis.
Classification
| Field | Value |
|---|---|
| Device name | Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid |
| Device class | Class II |
| Regulation | 21 CFR 882.1450 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for PIW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 92 |
| 2019 | 2 | 128 |
| 2023 | 1 | 181 |
| 2025 | 1 | 143 |
Compare with all 510(k) review times · Search every PIW clearance
Top PIW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Brainscope Company, Inc. | 6 | 2019-09-11 |
| Headsafe Mfg Pty, Ltd. | 2 | 2025-03-27 |
Most recent PIW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243426 | Headsafe Mfg Pty, Ltd. | Nurochek-Pro System | 2025-03-27 | 143 |
| K231914 | Headsafe Mfg Pty, Ltd. | Nurochek-II System | 2023-12-27 | 181 |
| K190815 | Brainscope Company, Inc. | BrainScope TBI | 2019-09-11 | 166 |
| K183241 | Brainscope Company, Inc. | BrainScope TBI (Model: Ahead 400) | 2019-02-19 | 90 |
| K181785 | Brainscope Company, Inc. | Modified BrainScope One | 2018-12-19 | 169 |
Recalls for PIW devices
openFDA lists no recalls for product code PIW.
Frequently asked questions
What is FDA product code PIW?
PIW is the FDA product code for brain injury adjunctive interpretive electroencephalograph assessment aid. It is a Class II device, regulated under 21 CFR 882.1450 and reviewed by the Neurology panel.
What device class is PIW?
Class II, regulation 21 CFR 882.1450. Typical premarket route: 510(k).
How long does a 510(k) take for product code PIW?
Across 8 cleared submissions the average was 134 days from receipt to decision (median 152).
Which companies have the most PIW clearances?
Brainscope Company, Inc. (6); Headsafe Mfg Pty, Ltd. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code PIW
- Run a recall and safety report across every PIW manufacturer
- Watch product code PIW 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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