510(k) · Cleared

Cleared

Vertigone BPPV Goggle

K082634510(k) TraditionalCleared Apr 7, 2009209-day reviewClass U

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

Vertigone, Inc. · LXV Apparatus, Vestibular Analysis

Cleared on Apr 7, 2009 as substantially equivalent to K070085 (Medicaa (Uruguay) S.A., 2007) after a 209-day review. Its family tree reaches back 2 generations to 1995.

Decided: Apr 7, 2009
Review: 209 days
Class: Class U
Product code: LXV
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K946229 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK946229 Balance ManagerNeurocom International, Inc. · 1995
1 generation backK070085 Balance Rehabilitation Unit (Bru)Medicaa (Uruguay) S.A. · 2007
This deviceK082634 Vertigone BPPV GoggleVertigone, Inc. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K946229	Balance Manager	Neurocom International, Inc.	1995	—
−1	K070085	Balance Rehabilitation Unit (Bru)	Medicaa (Uruguay) S.A.	2007	—
0 (this device)	K082634	Vertigone BPPV Goggle	Vertigone, Inc.	2009	—

FIG. 1 — Lineage of K082634, 1995–2009Source: 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 LXV? 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 LXV device

#1 K220231 GyroStimscore 3.8 · 3 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? (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
*	K070085	Balance Rehabilitation Unit (Bru) Summary page 2 …2 === Panel: Ear, Nose and Throat 4. Predicate Device: Device: BRUTM - Balance Rehabilitation Unit Manufacturer: Medicaa (Uruguay) S.A. Approval 510(k) #: K070085 5. Device Description: The VertiGONE BPPV Goggle is a head mounted medical device worn by the patient. The VertiGONE Gogg…	Medicaa (Uruguay) S.A.	2007	—

Also cleared against K070085: 2 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 14 years and passes through 3 companies; a new generation was cleared every 11.6 years on median.
None of the 2 ancestors has a recall.
2 other devices also cite its predicate K070085.

How does its category compare?

All LXV devices

LXV Apparatus, Vestibular Analysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · LXV

1in 2022

2007high 2 (2007) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LXV

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

Recalls per year · LXV

1in 2009

2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · LXV

1in 2010

2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code LXV, 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	1
2008	2	—	1	0
2009	1	—	1	0
2010	1	—	0	1
2011	0	—	0	0
2012	1	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	1	—	0	0
2019	2	—	0	0
2020	2	—	0	0
2021	0	—	0	0
2022	1	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The VertiGONE goggle is indicated for the treatment of Benign Paroxysmal Positional Vertigo (BPPV). The VertiGONE goggle guides the practitioner to move the patient's head accurately through the Epley, or canalith repositioning maneuver.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082634 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082634: Vertigone BPPV Goggle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082634

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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