# K160499: Apnea Risk Evaluation System (ARES), Model 620

- Pathway: 510(k) (Traditional)
- Applicant: Watermark Medical
- Decided: Apr 24, 2017 after 426 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: 4 generations back to K873535 (1987). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111194: Apnea Risk Evaluation System (Ares), Advanced Brain Monitoring, Inc. (2011) Summary page 4.

## Indications for use
The Apnea Risk Evaluation System (ARES), Model 620 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 the patient’s home to aid a physician in diagnosing adults with possible sleep-related breathing disorders.

Source page: https://510kreport.com/device/K160499
Methodology: https://510kreport.com/methodology