# K251506: Nelli (Version 7.11)

- Pathway: 510(k) (Traditional)
- Applicant: Neuro Event Labs OY
- Decided: Nov 21, 2025 after 189 days
- Product code: POS (Physiological Signal Based Seizure Monitoring System)
- Device class: 2
- Regulation: 21 CFR 882.1580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN140033 (2017). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181861: Embrace, Empatica S.r.l. (2018) Summary page 5.

## Indications for use
Nelli is indicated for use as an adjunct to seizure monitoring of patients aged 18 years and above in healthcare facilities during periods of rest. The device utilizes automated analysis of audio and video (media) to identify epileptic and non-epileptic seizure events with a positive motor component. The system provides prioritization of identified major seizures and other motor events for review and media playback by a qualified healthcare professional.

Source page: https://510kreport.com/device/K251506
Methodology: https://510kreport.com/methodology