# K181077: ActiGraph CentrePoint Insight Watch

- Pathway: 510(k) (Special)
- Applicant: Actigraph
- Decided: May 24, 2018 after 30 days
- Product code: LEL (Device, Sleep Assessment)
- Device class: 2
- Regulation: 21 CFR 882.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K854030 (1986). 5 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080545: Actitrainer, Actigraph, LLC (2008) Summary page 4.

## Most influential descendants
- K221282: Empatica Health Monitoring Platform (2022), 7 descendants of its own
- K230457: Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (2023), 4 descendants of its own
- K252981: EmbraceMini (2025), 1 descendant of its own
- K232915: EpiMonitor (2024), 1 descendant of its own
- K231532: ActiGraph LEAP activity monitor (ActiGraph LEAP) (2023), 1 descendant of its own

## Indications for use
The ActiGraph CentrePoint Insight Watch is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. The Insight watch can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

Source page: https://510kreport.com/device/K181077
Methodology: https://510kreport.com/methodology