VISIONAIR is an AI-enabled medical device from PacificMD Biotech Llc that the U.S. FDA cleared through 510(k) K221892 on October 5, 2022. Its lead review panel is Anesthesiology and its primary product code is BXQ (Rhinoanemometer (Measurement Of Nasal Decongestion)).
See also all FDA AI clearances in 2022, top anesthesiology AI devices.
Key facts
| Submission number | K221892 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | PacificMD Biotech Llc |
| Lead review panel | Anesthesiology |
| Primary product code | BXQ — Rhinoanemometer (Measurement Of Nasal Decongestion) |
| Applicant (openFDA) | Pacificmd Biotech, LLC |
| Applicant location | Henderson, NV, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 868.1800 |
| 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. VISIONAIR went through this pathway (K221892).
openFDA lists it as a Class 2 device under 21 CFR 868.1800. Class II devices are moderate risk and are subject to general and special controls.
Product code BXQ covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. PacificMD Biotech Llc 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.