FDA product code QNX: External Compression Device For Internal Jugular Vein Compression

QNX is the FDA product code for external compression device for internal jugular vein compression. It is a Class II device, regulated under 21 CFR 890.3050 and reviewed by the Physical Medicine panel. Devices under QNX reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

Definition

External compression device for internal jugular vein compression. An external compression device for internal jugular vein compression is a non-invasive device that is intended to increase intracranial blood volume to reduce the occurrence of specific changes in the brain following head impacts sustained from the environment of use.

Classification

Recalls for QNX devices

openFDA lists no recalls for product code QNX.

HCPCS codes with matching descriptors

Text match between the FDA device name and CMS descriptors, not an official crosswalk:

• L8614 — Cochlear device, includes all internal and external components

Frequently asked questions

What is FDA product code QNX?

QNX is the FDA product code for external compression device for internal jugular vein compression. It is a Class II device, regulated under 21 CFR 890.3050 and reviewed by the Physical Medicine panel.

What device class is QNX?

Class II, regulation 21 CFR 890.3050. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code QNX
• Run a recall and safety report across every QNX manufacturer
• Watch product code QNX for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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