Personalized Therapy Comfort Settings (PTCS) is an AI-enabled medical device from ResMed Corp that the U.S. FDA cleared through 510(k) K251657 on December 5, 2025. Its lead review panel is Anesthesiology and its primary product code is BZD (Ventilator, Non-Continuous (Respirator)).
See also FDA-cleared AI anesthesiology devices in 2025, all FDA AI clearances in 2025, top anesthesiology AI devices.
Key facts
| Submission number | K251657 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | ResMed Corp |
| Lead review panel | Anesthesiology |
| Primary product code | BZD — Ventilator, Non-Continuous (Respirator) |
| Applicant (openFDA) | Resmed Corp |
| Applicant location | San Diego, CA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 868.5905 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Personalized Therapy Comfort Settings (PTCS) went through this pathway (K251657).
openFDA lists it as a Class 2 device under 21 CFR 868.5905. Class II devices are moderate risk and are subject to general and special controls.
Product code BZD covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. ResMed Corp has 1 AI-enabled device on the list, and the Anesthesiology panel accounts for 30 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.