FDA product code POS: Physiological Signal Based Seizure Monitoring System
POS is the FDA product code for physiological signal based seizure monitoring system. It is a Class II device, regulated under 21 CFR 882.1580 and reviewed by the Neurology panel. FDA has cleared 9 510(k) submissions under POS, 5 in the last five years, from 5 different applicants. The average 510(k) review took 197 days (median 161); 162 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for POS devices, 1 initiated in the last five years.
Definition
The Physiological signal based seizure monitoring system is a prescription device that uses physiological signal to identify abnormal physiological activity that may be associated with a seizure. The System does not predict seizure onsets, and is not intended as a standalone seizure monitoring device.
Classification
| Field | Value |
|---|---|
| Device name | Physiological Signal Based Seizure Monitoring System |
| Device class | Class II |
| Regulation | 21 CFR 882.1580 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for POS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 142 |
| 2019 | 1 | 271 |
| 2021 | 1 | 368 |
| 2024 | 1 | 149 |
| 2025 | 4 | 176 |
Top POS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Empatica S.r.l. | 4 | 2025-06-19 |
| Brain Sentinel, Inc. | 2 | 2021-02-06 |
| Neuro Event Labs OY | 1 | 2025-11-21 |
| Livassured BV | 1 | 2025-07-12 |
| Epiwatch, Inc. | 1 | 2025-03-07 |
Most recent POS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251506 | Neuro Event Labs OY | Nelli (Version 7.11) | 2025-11-21 | 189 |
| K243199 | Livassured BV | NightWatch+ US | 2025-07-12 | 284 |
| K250515 | Empatica S.r.l. | EpiMonitor | 2025-06-19 | 118 |
| K243515 | Epiwatch, Inc. | EpiWatch Monitoring System | 2025-03-07 | 114 |
| K232915 | Empatica S.r.l. | EpiMonitor | 2024-02-15 | 149 |
Recalls for POS devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-07-13.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code POS?
POS is the FDA product code for physiological signal based seizure monitoring system. It is a Class II device, regulated under 21 CFR 882.1580 and reviewed by the Neurology panel.
What device class is POS?
Class II, regulation 21 CFR 882.1580. Typical premarket route: 510(k).
How long does a 510(k) take for product code POS?
Across 9 cleared submissions the average was 197 days from receipt to decision (median 161).
Which companies have the most POS clearances?
Empatica S.r.l. (4); Brain Sentinel, Inc. (2); Neuro Event Labs OY (1); Livassured BV (1); Epiwatch, Inc. (1).
Have POS devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-07-13.
Next steps
- Run an FDA pathway report with predicate devices for product code POS
- Run a recall and safety report across every POS manufacturer
- Watch product code POS 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.