# K111314: Morpheus OX

- Pathway: 510(k) (Traditional)
- Applicant: Widemed, Ltd.
- Decided: Aug 31, 2011 after 113 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: 7 generations back to K913396 (1992). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070326: Noga Automated Sleep Study Scoring and Data Management System, Widemed, Ltd. (2007) Summary page 1.
- K070263: Apnealink, Resmed Germany, Inc. (2007) Summary page 1.
- K071230: Apnea Risk Evaluation System (Ares), Model 600, Advanced Brain Monitoring, Inc. (2007) Summary page 1.
- K060708: Somnoscreen, Somnomedics GmbH & Co. KG (2007) Summary page 1.

## Indications for use
The Morpheus Ox Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid in the detection of Cheyne-Stokes Respiration (CSR), and to estimate Apnea Hypopnea Index (AHI), in a Cardiac patient population that is suspected of having Sleep Disordered Breathing (SDB). The Morpheus Ox System is intended to be used for analysis, display, redisplay (retrieve), reports generation and networking of physiological data received from an oximeter device. It does not perform automatic classification of respiratory events as central or obstructive. This system is to be used under the supervision of a physician. Morpheus Ox displays heart rate, saturation and photoplethysmograph signals, acquired from an oximeter device. Morpheus Ox may also display signals including: EtCO2, Respiratory impedance, Plethysmograph Derived Respiratory (PDR) calculated signal, Activity, ECG, EEG, P flow, T flow, C flow, EMG, EOG, Snore, Leg movement, Abdomen, Thorax, EPAP, IPAP.

Source page: https://510kreport.com/device/K111314
Methodology: https://510kreport.com/methodology