# POS: Physiological Signal Based Seizure Monitoring System

- Device class: 2; regulation: 21 CFR 882.1580; FDA's rule: 510(k) required
- FDA decisions: 10
- 510(k) review time 2021–2025: median 169 days (middle half 126–260)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 1
- 2018: 2
- 2019: 1
- 2021: 1
- 2024: 1
- 2025: 4

## Most-cited predicates
- K181861: Embrace (2018), cited by 4
- DEN140033: Companion (2017), cited by 2
- K182180: SPEAC System (2019), cited by 1
- K232915: EpiMonitor (2024), cited by 1
- K172935: Embrace (2018), cited by 1

Source page: https://510kreport.com/product-code/POS
Data by year (CSV): https://510kreport.com/product-code/POS.csv