510(k) · Cleared

Cleared

Retitrack

K222484510(k) TraditionalCleared May 9, 2023265-day reviewClass II21 CFR 886.1510

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

C. Light Technologies, Inc. · HLL Monitor, Eye Movement

Cleared on May 9, 2023 as substantially equivalent to K152890 (Ober Consulting Sp. Z.O.O., 2016) after a 265-day review. Its family tree reaches back 2 generations to 1990.

Decided: May 9, 2023
Review: 265 days
Class: Class II
Product code: HLL
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K902954 (1990). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK902954 OBER2 Monitor, Eye Movement (Ophthalmic)Permobil AB · 1990
1 generation backK152890 Saccadometer Plus, Saccadometer AdvancedOber Consulting Sp. Z.O.O. · 2016
This deviceK222484 RetitrackC. Light Technologies, Inc. · 2023

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K902954	OBER2 Monitor, Eye Movement (Ophthalmic)	Permobil AB	1990	—
−1	K152890	Saccadometer Plus, Saccadometer Advanced	Ober Consulting Sp. Z.O.O.	2016	—
0 (this device)	K222484	Retitrack	C. Light Technologies, Inc.	2023	—

FIG. 1 — Lineage of K222484, 1990–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HLL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K152890	Saccadometer Plus, Saccadometer Advanced Summary page 4 …ement Monitor Device Classification: Class II (21 CFR 886.1510) Product Code: HLL Predicate Device: Saccadometer Plus (K152890) Class II (21 CFR 886.1510); Product Code HLL Applicant: Ob…	Ober Consulting Sp. Z.O.O.	2016	—
†	K181771	RightEye Vision System	Righteye, LLC	2018	—
†	K150320	Compass	Centervue S.P.A.	2015	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 33 years and passes through 3 companies; a new generation was cleared every 26.0 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All HLL devices

HLL Monitor, Eye Movement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · HLL

1in 2023

2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HLL

Too few HLL 510(k)s in any year since 2007 to give a median.

Recalls per year · HLL

No recall names HLL since 2007.

Adverse event reports per year · HLL

No MAUDE report names HLL since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	1	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	1	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

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).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K222484 · printed Nov 5, 2026

Cite this page

510(k) Report. “K222484: Retitrack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222484

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026