# K222484: Retitrack

- Pathway: 510(k) (Traditional)
- Applicant: C. Light Technologies, Inc.
- Decided: May 9, 2023 after 265 days
- Product code: HLL (Monitor, Eye Movement)
- Device class: 2
- Regulation: 21 CFR 886.1510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K902954 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152890: Saccadometer Plus, Saccadometer Advanced, Ober Consulting Sp. Z.O.O. (2016) Summary page 4.

## Indications for use
The Retitrack™ is intended for recording, viewing, measuring, and analyzing temporal characteristics of fixation and saccadic responses when viewing a visual stimulus. The Retitrack™ is intended for use by healthcare practitioners in healthcare settings (e.g., physician’s office, clinic, laboratory).

Source page: https://510kreport.com/device/K222484
Methodology: https://510kreport.com/methodology