# K965079: Somnitor 32K Sleep Activity Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Neurim Pharmaceuticals, Ltd.
- Decided: Jul 10, 1997 after 203 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: 1 generation back to K854030 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K854030: Wrist Actigraph, Ambulatory Monitoring, Inc. (1986) Summary page 1.

## Indications for use
The Somnitor 32K Activity Monitor is intended to monitor physical activity with an ambulatory device and after downloading the data to a personal computer, determine the periods when the patient was awake or sleeping using a validated algorithm.

Source page: https://510kreport.com/device/K965079
Methodology: https://510kreport.com/methodology