# K231546: Somfit

- Pathway: 510(k) (Traditional)
- Applicant: Compumedics Limited
- Decided: Nov 30, 2023 after 184 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- 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 K913396 (1992). 49 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180775: Watch-PAT300, Itamar Medical, Ltd. (2018) Summary page 5.

## Most influential descendants
- K252383: Somfit D (2025), 0 descendants of its own

## Indications for use
The Somfit system is a non-invasive prescription device for home use with patients suspected to have sleep-related breathing disorders. The Somfit is a diagnostic aid for the detection of sleep-related breathing disorders, sleep staging (REM, N1, N2, N3, Wake), and snoring level. The Somfit system acquires electrical data from three frontal electrodes, tri-axial accelerometer data, acoustic and plethysmographic data. The Somfit calculates and reports to clinicians EEG/EOG channels, Sleep Stages, SpO2, Peripheral Arterial Tonometry (PAT) signal, pulse rate, and snoring level. The Somfit calculates and reports to clinicians derived parameters such as PAT-derived Apnea Hypopnea Index, Obstructive Desaturation Index; and hypnogram-derived indices such as time in each sleep stage. Somfit data is not intended to be used as the sole or primary basis for diagnosing any sleep-related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted. The Somfit is not intended for use as life support equipment, for example vital signs monitoring in intensive care unit. The Somfit is a prescription device indicated for adult patients aged 21 years and over.

Source page: https://510kreport.com/device/K231546
Methodology: https://510kreport.com/methodology