# K200654: Rubicon SA System

- Pathway: 510(k) (Traditional)
- Applicant: Dymedix Diagnostics, Inc.
- Decided: Jul 22, 2020 after 132 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: 2 generations back to K002135 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022294: Apneacheck, Im Systems (2003) Summary page 4.

## Indications for use
The Rubicon screening device is a small battery-powered device designed to assess and record nasal and oral airflow in adult patient during sleep in the home setting. The device is intended as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography (PSG) based on the patient's test data.

Source page: https://510kreport.com/device/K200654
Methodology: https://510kreport.com/methodology