# K200565: Galapogos

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Corp
- Decided: Jan 17, 2021 after 319 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: 10 generations back to K913396 (1992). 51 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160836: Menai System, Resmed, Ltd. (2016) Summary page 4.

## Most influential descendants
- K241216: myAir (2024), 2 descendants of its own
- K250624: myAir (2025), 1 descendant of its own
- K251657: Personalized Therapy Comfort Settings (PTCS) (2025), 0 descendants of its own

## Indications for use
The Galapagos app is intended for patients who are prescribed a compatible ResMed S10 platform device to simulate therapy prior to using their device with their prescribed settings. It is an optional software accessory to allow patients to acclimate to their therapy device.

Source page: https://510kreport.com/device/K200565
Methodology: https://510kreport.com/methodology