About this listing
CASSIE from Wesper, Inc. appears on the U.S. FDA list of AI-enabled medical devices under submission K252628. It went through the 510(k) pathway, reviewed by the Anesthesiology panel, with an FDA decision dated April 27, 2026. Its primary FDA product code is MNR.
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
- CASSIE
- Company
- Wesper, Inc.
- Submission number
- K252628
- Pathway
- 510(k)
- Decision date
- Apr 27, 2026
- Specialty (lead panel)
- Anesthesiology
- Primary product code
- MNR
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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.