# K223922: Somnum (V.1.1.2.)

- Pathway: 510(k) (Traditional)
- Applicant: Honeynaps Co., Ltd.
- Decided: Aug 16, 2023 after 229 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.
1 later device descends from it; 1 cites it directly.
0 of 37 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 5.
- K112102: Michele Sleep Scoring Systems, Younes Sleep Technologies (2011) Summary page 6.

## Most influential descendants
- K253390: Somnum (Somnum) (2026), 0 descendants of its own

## Indications for use
SOMNUM is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders. SOMNUM is intended to be used for analysis (automatic scoring and manual re-scoring), display, redisplay(retrieve), summarize and reports generation of digital data collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders. The device is to be used under the supervision of a physician. Use is restricted to files obtained from adult patients. For respiratory events - Sleep Disordered Breathing (Apneas and Hypopneas)- obstructive, central, mixed apneas, and hypopneas must be manually scored by physician. The device does not output specific apnea or hypopnea events and therefore should not be used for management decisions.

Source page: https://510kreport.com/device/K223922
Methodology: https://510kreport.com/methodology