# K022294: Apneacheck

- Pathway: 510(k) (Traditional)
- Applicant: Im Systems
- Decided: Apr 25, 2003 after 283 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: 1 generation back to K002135 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002135: Sleepstrip Disposable Apnea Screener, Influent, Ltd. (2000)

## Most influential descendants
- K200654: Rubicon SA System (2020), 0 descendants of its own

## Indications for use
The Sleepcheck is a small monitor designed to assess nasal and oral airflow. Apnea breathing events are counted based on a reduction in airflow. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient’s score.

Source page: https://510kreport.com/device/K022294
Methodology: https://510kreport.com/methodology