# K111194: Apnea Risk Evaluation System (Ares)

- Pathway: 510(k) (Special)
- Applicant: Advanced Brain Monitoring, Inc.
- Decided: Jul 7, 2011 after 70 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 K873535 (1987). 13 ancestors in all.
40 later devices descend from it; 2 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110705: Apnea Risk Evaluation System (Ares), Advanced Brain Monitoring, Inc. (2011) Summary page 3.
- K090484: Alice PDX, Respironics Inc., Sleep & Home Respiratory Group (2009) Summary page 3.
- K072201: Compumedics Somte PSG Recording System, Compumedics Limited (2008) Summary page 3.

## Most influential descendants
- K112514: Apnea Risk Evaluation System (Ares) (2012), 38 descendants of its own
- K120447: X4 (2012), 18 descendants of its own
- K130013: X4 System (2013), 17 descendants of its own
- K120450: Sleep Profiler (2012), 16 descendants of its own
- K131383: X10 Headset with X-Series Basic Software, X24 Headset with X-Series Basic Software (2013), 14 descendants of its own

## Indications for use
The Apnea Risk Evaluation System (ARES), Model 610 is indicated for use in the diagnostic evaluation by a physician of adult patients with possible sleep apnea. The ARES can record and score respiratory events during sleep (e.g., apneas, hypopneas, mixed apneas and flow limiting events). The device is designed for prescription use in home diagnosis of adults with possible sleep-related breathing disorders.

Source page: https://510kreport.com/device/K111194
Methodology: https://510kreport.com/methodology