# K243513: DCM (PW-DCM)

- Pathway: 510(k) (Traditional)
- Applicant: Pneumowave, Ltd.
- Decided: Apr 16, 2025 after 155 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: 7 generations back to K854030 (1986). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231532: ActiGraph LEAP activity monitor (ActiGraph LEAP), Actigraph, LLC (2023) Summary page 5.

## Indications for use
DCM 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. DCM can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable. DCM is indicated for monitoring of adult patients only.

Source page: https://510kreport.com/device/K243513
Methodology: https://510kreport.com/methodology