# DEN200017: Q-Collar

- Pathway: De Novo (Direct)
- Applicant: Q30 Sports Science, LLC
- Decided: Feb 26, 2021 after 344 days
- Product code: QNX (External Compression Device For Internal Jugular Vein Compression)
- Device class: 2
- Regulation: 21 CFR 890.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Q-Collar is a non-invasive device intended to be worn around the neck of athletes aged 13 years and older during sports activities to aid in the protection of the brain from effects associated with repetitive sub-concussive head impacts.

Source page: https://510kreport.com/device/DEN200017
Methodology: https://510kreport.com/methodology