d-Nav System is an AI-enabled medical device from Hygieia, Inc that the U.S. FDA cleared through 510(k) K181916 on February 4, 2019. Its lead review panel is Anesthesiology and its primary product code is NDC (Calculator, Drug Dose).
See also all FDA AI clearances in 2019, top anesthesiology AI devices.
Key facts
| Submission number | K181916 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Hygieia, Inc |
| Lead review panel | Anesthesiology |
| Primary product code | NDC — Calculator, Drug Dose |
| Applicant (openFDA) | Hygieia, Inc. |
| Applicant location | Livonia, MI, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 868.1890 |
| 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. d-Nav System went through this pathway (K181916).
openFDA lists it as a Class 2 device under 21 CFR 868.1890. Class II devices are moderate risk and are subject to general and special controls.
Product code NDC covers 2 devices on the FDA AI list. By decision date, this device is #2 of 2 under that code. Hygieia, 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.