# K242224: Happy Health Home Sleep Test

- Pathway: 510(k) (Traditional)
- Applicant: Happy Health, Inc.
- Decided: Jun 18, 2025 after 324 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.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191031: NightOwl, Ectosense NV (2020) Summary page 5.

## Indications for use
The Happy Health Home Sleep Test is a Software as a Medical Device that uses data from wearable devices to record, analyze, display, export, and store biophysical parameters to aid in evaluating sleep‐related breathing disorders of adult patients suspected of sleep apnea. The device is intended for use on individuals who are 22 years of age or older in clinical and home settings under the direction of a trained healthcare provider.

Source page: https://510kreport.com/device/K242224
Methodology: https://510kreport.com/methodology