510(k) · Anesthesiology

Huxley SANSA Home Sleep Apnea Test (1000-00)

by Huxley Medical

Huxley SANSA Home Sleep Apnea Test (1000-00) is an AI-enabled medical device from Huxley Medical that the U.S. FDA cleared through 510(k) K240285 on July 15, 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 numberK240285
Pathway510(k)
Date of final decision
Company (FDA list)Huxley Medical
Lead review panelAnesthesiology
Primary product codeMNR — Ventilatory Effort Recorder
Applicant (openFDA)Huxley Medical
Applicant locationAtlanta, GA, 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. Huxley SANSA Home Sleep Apnea Test (1000-00) went through this pathway (K240285).

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 #6 of 12 under that code. Huxley Medical has 4 AI-enabled devices 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)

More from Huxley Medical