# K183661: ClearEdge Balance System

- Pathway: 510(k) (Traditional)
- Applicant: Quadrant Biosciences
- Decided: Oct 22, 2019 after 299 days
- Product code: LXV (Apparatus, Vestibular Analysis)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K911795 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121590: Vestibular Analysis Apparatus, Capacity Sports, LLC (2012) Summary page 4.

## Indications for use
The ClearEdge® Balance System is intended for use to assess sway as an indicator of balance. Individual suitability for assessment must be judged on a case by case basis, by a qualified individual including those certified and/or licensed in their state to prescribe and/or use balance devices such as certified athletic trainers, physical therapists, chiropractors, nurses and physicians. The ClearEdge® Balance System can be used wherever compatible Android mobile operating devices can be used.

Source page: https://510kreport.com/device/K183661
Methodology: https://510kreport.com/methodology