FDA product code POM: Computerized Cognitive Assessment Aid For Concussion
POM is the FDA product code for computerized cognitive assessment aid for concussion. It is a Class II device, regulated under 21 CFR 882.1471 and reviewed by the Neurology panel. FDA has cleared 7 510(k) submissions under POM, 2 in the last five years, from 3 different applicants. The average 510(k) review took 153 days (median 117); 243 days on average over the last three years. 1 De Novo request was granted under it.
Definition
For use as an assessment aid in the management of concussion.
Classification
| Field | Value |
|---|---|
| Device name | Computerized Cognitive Assessment Aid For Concussion |
| Device class | Class II |
| Regulation | 21 CFR 882.1471 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for POM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 74 |
| 2018 | 1 | 165 |
| 2020 | 1 | 116 |
| 2021 | 1 | 303 |
| 2023 | 1 | 99 |
| 2025 | 1 | 243 |
Compare with all 510(k) review times · Search every POM clearance
Top POM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Impact Applications, Inc. | 5 | 2023-09-16 |
| Sway Medical, Inc. | 1 | 2025-02-15 |
| Vista Lifesciences, Inc. | 1 | 2021-03-25 |
Most recent POM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241737 | Sway Medical, Inc. | Sway System Sports Plus | 2025-02-15 | 243 |
| K231688 | Impact Applications, Inc. | ImPACT Version 4 | 2023-09-16 | 99 |
| K201376 | Vista Lifesciences, Inc. | ANAM Test System | 2021-03-25 | 303 |
| K202485 | Impact Applications, Inc. | ImPACT Version 4 | 2020-12-25 | 116 |
| K181223 | Impact Applications, Inc. | ImPACT | 2018-10-20 | 165 |
Recalls for POM devices
openFDA lists no recalls for product code POM.
Frequently asked questions
What is FDA product code POM?
POM is the FDA product code for computerized cognitive assessment aid for concussion. It is a Class II device, regulated under 21 CFR 882.1471 and reviewed by the Neurology panel.
What device class is POM?
Class II, regulation 21 CFR 882.1471. Typical premarket route: 510(k).
How long does a 510(k) take for product code POM?
Across 7 cleared submissions the average was 153 days from receipt to decision (median 117).
Which companies have the most POM clearances?
Impact Applications, Inc. (5); Sway Medical, Inc. (1); Vista Lifesciences, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code POM
- Run a recall and safety report across every POM manufacturer
- Watch product code POM 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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