# K253390: Somnum (Somnum)

- Pathway: 510(k) (Traditional)
- Applicant: Honeynaps Co., Ltd.
- Decided: Jun 27, 2026 after 270 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: 10 generations back to K962603 (1997). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223922: Somnum (V.1.1.2.), Honeynaps Co., Ltd. (2023) Summary page 5.

## Indications for use
SOMNUM is an Al-enabled software program intended for use as an aid in the diagnosis of sleep and respiratory-related sleep disorders. SOMNUM is intended to be used for analysis — including automatic scoring using Al/ML algorithms for sleep stage classification, arousal detection, respiratory event detection, and leg movement event detection, as well as manual scoring/re-scoring, display, redisplay (retrieve), summarization, and report 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 data obtained from adult patients.

Source page: https://510kreport.com/device/K253390
Methodology: https://510kreport.com/methodology