Personalized Therapy Comfort Settings (PTCS) is an AI-enabled medical device from ResMed Corp, listed by FDA (510(k), K251657) with a decision date of 2025-12-05. Review panel: Anesthesiology.
| FDA submission number | K251657 |
|---|---|
| Pathway | 510(k) |
| Company | ResMed Corp |
| Review panel (specialty) | Anesthesiology |
| FDA decision date | 2025-12-05 |
| Decision | Substantially Equivalent |
| Product code | BZD |
| Classification | Ventilator, Non-Continuous (Respirator) |
| Device class | 2 |
| Regulation number | 868.5905 |
| Review time (calendar days) | 189 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Anesthesiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.