Air Next is an AI-enabled medical device from NuvoAir AB that the U.S. FDA cleared through 510(k) K183089 on January 2, 2020. Its lead review panel is Anesthesiology and its primary product code is BZG (Spirometer, Diagnostic).
See also all FDA AI clearances in 2020, top anesthesiology AI devices.
Key facts
| Submission number | K183089 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | NuvoAir AB |
| Lead review panel | Anesthesiology |
| Primary product code | BZG — Spirometer, Diagnostic |
| Applicant (openFDA) | Nuvoair AB |
| Applicant location | Stockholm, SE |
| Device class | Class 2 |
| Regulation number | 21 CFR 868.1840 |
| 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. Air Next went through this pathway (K183089).
openFDA lists it as a Class 2 device under 21 CFR 868.1840. Class II devices are moderate risk and are subject to general and special controls.
Product code BZG covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. NuvoAir AB 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.