# K071230: Apnea Risk Evaluation System (Ares), Model 600

- Pathway: 510(k) (Special)
- Applicant: Advanced Brain Monitoring, Inc.
- Decided: Oct 3, 2007 after 153 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 K003154 (2001). 3 ancestors in all.
43 later devices descend from it; 2 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041662: Apnea Risk Evaluation System (Ares), Advanced Brain Monitoring, Inc. (2004) Summary page 1.
- K003154: Mizar, Basis BE, Sandman Digital, Eb Neuro S.P.A. (2001) Summary page 1.
- K042916: Watch Pat 100S, Itamar Medical (2004) Summary page 1.

## Most influential descendants
- K110705: Apnea Risk Evaluation System (Ares) (2011), 41 descendants of its own
- K111194: Apnea Risk Evaluation System (Ares) (2011), 40 descendants of its own
- 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

## Indications for use
The Apnea Risk Evaluation System (ARES) 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/K071230
Methodology: https://510kreport.com/methodology