# K221179: SomnoMetry

- Pathway: 510(k) (Traditional)
- Applicant: Neumetry Medical, Inc.
- Decided: Sep 21, 2022 after 149 days
- Product code: OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K962603 (1997). 35 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162627: EnsoSleep, Ensodata, Inc. (2017) Summary page 4.

## Most influential descendants
- K241288: Noxturnal Web (2024), 2 descendants of its own
- K261747: Report Studio (2026), 0 descendants of its own
- K260585: Noxturnal Web (2026), 0 descendants of its own

## Indications for use
SomnoMetry is intended for use for the diagnostic evaluation by a physician to assess sleep quality and as an aid for the diagnosis of sleep and respiratory-related sleep disorders in adults only. SomnoMetry is a software-only medical device to be used to analyze physiological signals and automatically score sleep study results, including the staging of sleep, AHI, and detection of sleep-disordered breathing events including obstructive apneas. It is intended to be used under the supervision of a clinician in a clinical environment. All automatically scored events are subject to verification by a qualified clinician.

Source page: https://510kreport.com/device/K221179
Methodology: https://510kreport.com/methodology