# K252497: Sansa Hsat

- Pathway: 510(k) (Traditional)
- Applicant: Huxley Medical
- Decided: Dec 10, 2025 after 124 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: 13 generations back to K913396 (1992). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K244027: Sansa Hsat, Huxley Medical (2025) Summary page 5.

## Indications for use
The Huxley Home Sleep Apnea Test (SANSA) is a wearable device intended for use in the recording, analysis and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adults suspected of sleep apnea. The device is intended for the clinical and home use setting under the direction of a Healthcare Professional (HCP)

Source page: https://510kreport.com/device/K252497
Methodology: https://510kreport.com/methodology