# K252383: Somfit D

- Pathway: 510(k) (Special)
- Applicant: Compumedics Limited
- Decided: Aug 28, 2025 after 28 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: 10 generations back to K913396 (1992). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231546: Somfit, Compumedics Limited (2023) Summary page 5.

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

Source page: https://510kreport.com/device/K252383
Methodology: https://510kreport.com/methodology