# K231532: ActiGraph LEAP activity monitor (ActiGraph LEAP)

- Pathway: 510(k) (Special)
- Applicant: Actigraph, LLC
- Decided: Jun 23, 2023 after 28 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: 6 generations back to K854030 (1986). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181077: ActiGraph CentrePoint Insight Watch, Actigraph (2018) Summary page 4.

## Most influential descendants
- K243513: DCM (PW-DCM) (2025), 0 descendants of its own

## Indications for use
The ActiGraph LEAP™ 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 ActiGraph LEAP™ 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/K231532
Methodology: https://510kreport.com/methodology