# K160836: Menai System

- Pathway: 510(k) (Traditional)
- Applicant: Resmed, Ltd.
- Decided: Dec 15, 2016 after 265 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K913396 (1992). 50 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140124: S9 Elouera, Resmed Corp (2014) Summary page 4.
- K905404: Medtronic Sullivan Nasal Cpap System, Medtronic Vascular (1991) Summary page 4.

## Most influential descendants
- K200565: Galapogos (2021), 3 descendants of its own
- K241216: myAir (2024), 2 descendants of its own
- K250624: myAir (2025), 1 descendant of its own
- K252338: MySleepDash (2026), 0 descendants of its own
- K251657: Personalized Therapy Comfort Settings (PTCS) (2025), 0 descendants of its own

## Indications for use
The Menai self-adjusting system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients (female patients with mild to moderate OSA when using AfH treatment mode) weighing more than 66 lb (30 kg). It is intended for home and hospital use. Monte Carlo is a mobile application for patients to remotely operate a prescribed compatible ResMed machine and transfer, analyze and display usage and therapeutic information. Monte Carlo also allows healthcare professionals to remotely configure compatible OSA therapy devices. The Menai FFM is a non-invasive accessory used for channeling airflow to a patient from a compatible ResMed machine such as a continuous positive airway pressure (CPAP) system. The Menai FFM is: • to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure therapy has been prescribed • intended for single-patient reuse in the home and hospital/institutional environment.

Source page: https://510kreport.com/device/K160836
Methodology: https://510kreport.com/methodology