FDA AI Clearance Tracker/K251657
Anesthesiology · 510(k)
Personalized Therapy Comfort Settings (PTCS)
ResMed Corp
About this listing
Personalized Therapy Comfort Settings (PTCS) from ResMed Corp appears on the U.S. FDA list of AI-enabled medical devices under submission K251657. It went through the 510(k) pathway, reviewed by the Anesthesiology panel, with an FDA decision dated December 5, 2025. Its primary FDA product code is BZD.
The FDA list records the regulatory facts above. For the device's cleared intended use, read the FDA decision summary linked at the bottom of this page.
- Device
- Personalized Therapy Comfort Settings (PTCS)
- Company
- ResMed Corp
- Submission number
- K251657
- Pathway
- 510(k)
- Decision date
- Dec 5, 2025
- Specialty (lead panel)
- Anesthesiology
- Primary product code
- BZD
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Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.