510(k) · Cleared

Cleared

Chronos Vision Eye Tracking Device (C-Etd)

K062015510(k) TraditionalCleared Oct 31, 2006106-day reviewClass II21 CFR 882.1460

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

Cleared on Oct 31, 2006 as substantially equivalent to K964325 (Micromedical Technologies, Inc., 1997) and 4 other predicates after a 106-day review. Its family tree reaches back 2 generations to 1994.

Decided: Oct 31, 2006
Review: 106 days
Class: Class II
Product code: GWN
Recalls: None
Predicates: 5

Its longest line of descent runs back 2 generations to K925111 (1994). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK925111 House Infrared/Video Electronystagmograph SystemEye Dynamics, Inc. · 1994
1 generation backK042529 Balanceback VNG SystemFall Prevention Technologies, LLC · 2004
This deviceK062015 Chronos Vision Eye Tracking Device (C-Etd)Chronos Vision · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K925111	House Infrared/Video Electronystagmograph System	Eye Dynamics, Inc.	1994	—
−1	K042529	Balanceback VNG System	Fall Prevention Technologies, LLC	2004	—
0 (this device)	K062015	Chronos Vision Eye Tracking Device (C-Etd)	Chronos Vision	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0
1999	1	0
2005	1	0

FIG. 1 — Lineage of K062015, 1994–2006Source: 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 GWN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GWN device

#1 K260566 SMARTVERTIGO™ Vestibular Assessment Systemscore 12.1 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (5)

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
*	K964325	Visualeyes: Video Eye Monitor Summary page 1 …onos Vision Eye Tracking Device (C-ETD) is substantially equivalent to a combination of the following devices: Micromedical Technologies Video Eye Monitor (K964325), SensoMotoric Instruments 2D VOG-Video-Oculography (K972243), Fall Prevention Technologies BalanceBack VNG (K042529), DDA…	Micromedical Technologies, Inc.	1997	—
*	K972243	2D Vog - Video-Oculography Summary page 1 …to a combination of the following devices: Micromedical Technologies Video Eye Monitor (K964325), SensoMotoric Instruments 2D VOG-Video-Oculography (K972243), Fall Prevention Technologies BalanceBack VNG (K042529), DDAT (UK) DDAT OMT (K050098) and Eye Dynamics House IRNVNG (K925…	Sensomotoric Instruments, GmbH	1997	—
*	K042529	Balanceback VNG System Summary page 1 …edical Technologies Video Eye Monitor (K964325), SensoMotoric Instruments 2D VOG-Video-Oculography (K972243), Fall Prevention Technologies BalanceBack VNG (K042529), DDAT (UK) DDAT OMT (K050098) and Eye Dynamics House IRNVNG (K9251 11). 4. Device Description The Chronos Visio…	Fall Prevention Technologies, LLC	2004	—
*	K050098	Ddat Omt Summary page 1 …Monitor (K964325), SensoMotoric Instruments 2D VOG-Video-Oculography (K972243), Fall Prevention Technologies BalanceBack VNG (K042529), DDAT (UK) DDAT OMT (K050098) and Eye Dynamics House IRNVNG (K9251 11). 4. Device Description The Chronos Vision Eye Tracking Device (C-ETD) facilit…	Ddat (Uk), Ltd.	2005	—
*	K925111	House Infrared/Video Electronystagmograph System Summary page 1 …nts 2D VOG-Video-Oculography (K972243), Fall Prevention Technologies BalanceBack VNG (K042529), DDAT (UK) DDAT OMT (K050098) and Eye Dynamics House IRNVNG (K9251 11). 4. Device Description The Chronos Vision Eye Tracking Device (C-ETD) facilitates measurement of three-dimension…	Eye Dynamics, Inc.	1994	—

Also cleared against K964325: 5 other devices →

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 12 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
None of the 6 ancestors has a recall.
5 other devices also cite its predicate K964325.

How does its category compare?

All GWN devices

GWN Nystagmograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GWN

3in 2025

2007high 4 (2017) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWN

203in 2025

2007high 203 (2025) · low 87 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GWN

1in 2013

2007high 1 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GWN

1in 2025

2007high 5 (2019) · low 0 (2007)2025

MAUDE reports naming product code GWN, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	0
2008	1	—	0	0
2009	1	—	0	0
2010	0	—	0	0
2011	0	—	0	0
2012	0	—	0	2
2013	3	88	1	0
2014	0	—	0	0
2015	3	165	0	0
2016	2	—	0	0
2017	4	160	0	0
2018	3	87	0	1
2019	1	—	0	5
2020	2	—	0	0
2021	0	—	0	1
2022	0	—	0	1
2023	1	—	0	3
2024	0	—	0	4
2025	3	203	0	1
2026	1	—	0	—

What is it indicated for?

The Chronos Vision Eye Tracking Device (C-ETD) is intended to provide information to assist in the diagnosis of vestibular disorders by measuring, recording, storing, displaying, and analyzing nystagmus of the eye. The C-ETD is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062015 · printed Nov 3, 2026

Cite this page

510(k) Report. “K062015: Chronos Vision Eye Tracking Device (C-Etd).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K062015

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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