# K251657: Personalized Therapy Comfort Settings (PTCS)

- Pathway: 510(k) (Traditional)
- Applicant: Resmed Corp
- Decided: Dec 5, 2025 after 189 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: 13 generations back to K913396 (1992). 54 ancestors in all.
No later device cites it as a predicate yet.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250624: myAir, Resmed Corp (2025) Summary page 5.

## Indications for use
Personalized Therapy Comfort Settings (“PTCS”) is an optional software accessory indicated for use by healthcare professionals and patients, providing recommended non-prescription comfort settings options to support patients when using their compatible Resmed PAP therapy device. The outputs provided by PTCS are optional recommendations and are not required to use the therapy device. It is intended for use in a home or clinical environment.

Source page: https://510kreport.com/device/K251657
Methodology: https://510kreport.com/methodology