Aurora is an AI-enabled medical device from EnsoData that the U.S. FDA cleared through 510(k) K231355 on February 9, 2024. Its lead review panel is Anesthesiology and its primary product code is MNR (Ventilatory Effort Recorder).
See also FDA-cleared AI anesthesiology devices in 2024, all FDA AI clearances in 2024, top anesthesiology AI devices.
Key facts
| Submission number | K231355 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | EnsoData |
| Lead review panel | Anesthesiology |
| Primary product code | MNR — Ventilatory Effort Recorder |
| Applicant (openFDA) | Ensodata |
| Applicant location | Madison, WI, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 868.2375 |
| 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. Aurora went through this pathway (K231355).
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 #5 of 12 under that code. EnsoData 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.