DeviceClearance

Product code QNX— Neurology

Q-Collar

Classification name
External Compression Device For Internal Jugular Vein Compression
Device class
Class 2
Regulation
21 CFR 890.3050
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QNX under 21 CFR 890.3050, via openFDA

Market context for product code QNX

FDA has cleared 1 device under product code QNX, all in 2021, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QNX

Recent clearances under product code QNX

Data sourced from openFDA. This site is unofficial and independent of the FDA.