510(k) · Anesthesiology

CASSIE

by Wesper, Inc.

CASSIE is an AI-enabled medical device from Wesper, Inc. that the U.S. FDA cleared through 510(k) K252628 on April 27, 2026. Its lead review panel is Anesthesiology and its primary product code is MNR (Ventilatory Effort Recorder).

See also all FDA AI clearances in 2026, top anesthesiology AI devices.

Key facts

Submission numberK252628
Pathway510(k)
Date of final decision
Company (FDA list)Wesper, Inc.
Lead review panelAnesthesiology
Primary product codeMNR — Ventilatory Effort Recorder
Applicant (openFDA)Wesper, Inc.
Applicant locationLong Island City, NY, US
Device classClass 2
Regulation number21 CFR 868.2375
Decision codeSESE
Submission typeTraditional

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. CASSIE went through this pathway (K252628).

openFDA lists it as a Class 2 device under 21 CFR 868.2375. Class II devices are moderate risk and are subject to general and special controls.

Product code MNR covers 12 devices on the FDA AI list. By decision date, this device is #11 of 12 under that code. Wesper, Inc. 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.

Similar devices (product code MNR)