# K213360: SleepCheckRx

- Pathway: 510(k) (Traditional)
- Applicant: Resapp Health
- Decided: Jul 5, 2022 after 266 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: 3 generations back to K002135 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173974: Drowzle, Resonea, Inc. (2019) Summary page 4.

## Indications for use
SleepCheckRx is indicated to record a patient’s respiratory pattern during sleep for the purpose of pre-screening patients for obstructive sleep apnea (OSA) syndrome. The device is designed for use in home-screening of adults (> 22 years of age) with suspected possible sleep breathing disorders. Results can be used to assist the healthcare professional in determining the need for further diagnosis and evaluation. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required.

Source page: https://510kreport.com/device/K213360
Methodology: https://510kreport.com/methodology