# K243199: NightWatch+ US

- Pathway: 510(k) (Traditional)
- Applicant: Livassured BV
- Decided: Jul 12, 2025 after 284 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 8.

## Indications for use
The NightWatch+ US is a prescription only device that is indicated for use as an adjunct to seizure monitoring of children age 4 till 16 diagnosed with epilepsy having Nocturnal Epileptic Major Motor Seizures which includes tonic-clonic (TC), tonic (if clustered or prolonged >30 seconds), hyperkinetic and TC-like seizures, in home or residential facilities during periods of rest. The Sensor of the device is worn on the upper arm and measures heart rate and motion data to detect patterns that may be associated with nocturnal epileptic motor seizures in patients with epilepsy. When a seizure event is detected by the Sensor of the NightWatch+ US, it sends a command to the paired wireless alarm station of the NightWatch+ US that is programmed to initiate an alarm to a designated caregiver. The system records and stores data from seizure events. The data can be viewed by the user in a cloud based data portal. The NightWatch+ US is not intended to diagnose specific seizure types.

Source page: https://510kreport.com/device/K243199
Methodology: https://510kreport.com/methodology