510(k) · Cleared
ClearedEpley Omniax
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vesticon · LXV Apparatus, Vestibular Analysis
Cleared on Jun 20, 2008 as substantially equivalent to K964325 (Micromedical Technologies, Inc., 1997) and 3 other predicates after a 339-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it.
- Decided
- Jun 20, 2008
- Review
- 339 days
- Class
- Class U
- Product code
- LXV
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K946229 (1995). 5 ancestors in all, the oldest K863424 (1987). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK946229 Balance ManagerNeurocom International, Inc. · 1995
- 1 generation backK070085 Balance Rehabilitation Unit (Bru)Medicaa (Uruguay) S.A. · 2007
- This deviceK071973 Epley OmniaxVesticon · 2008
- Descendant · cites it directly · 0 of its ownK220231 GyroStimUltrathera Technologies, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK192652 TRVInteracoustics A/S · 2020
- Descendant · cites it directly · 0 of its ownK081602 DizzyfixClearwater Clinical Limited · 2008
Most influential descendants
Showing 3 of 3 · See allView 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) | K071973 | Epley Omniax | Vesticon | 2008 | — |
| +1 | K220231 | GyroStim | Ultrathera Technologies, Inc. | 2022 | — |
| +1 | K192652 | TRV | Interacoustics A/S | 2020 | — |
| +1 | K081602 | Dizzyfix | Clearwater Clinical Limited | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
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
What was it cleared against? (4)
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 | Decided |
|---|---|---|---|
| * | K964325 | Visualeyes: Video Eye MonitorSummary page 1…lar analysis apparatus, LXV, unclassified and Nystagmograph, GWN, 882.1460, Class 11. Legally marketed device for substantial equivalence comparison: K(964325 - VisualEyes from MicroMedical Technologies, Inc. K863424 - Computer Eye Tracking System/ENG Exam Chair/Table from MicroMe… | 1997 |
| * | K863424 | Computer Eye Tracking Sys./Eng Exam. Chair & TableSummary page 1…graph, GWN, 882.1460, Class 11. Legally marketed device for substantial equivalence comparison: K(964325 - VisualEyes from MicroMedical Technologies, Inc. K863424 - Computer Eye Tracking System/ENG Exam Chair/Table from MicroMedical Technologies, Inc. K(922037 - System 2000… | 1987 |
| * | K922037 | System 2000, Rotational Vestibular ChairSummary page 1…isualEyes from MicroMedical Technologies, Inc. K863424 - Computer Eye Tracking System/ENG Exam Chair/Table from MicroMedical Technologies, Inc. K(922037 - System 2000 from MicroMedical Technologies, Inc. K(070085 - Balance Rehabilitation Unit from Medicaa, S.A. Description… | 1992 |
| * | K070085 | Balance Rehabilitation Unit (Bru)Summary page 1…puter Eye Tracking System/ENG Exam Chair/Table from MicroMedical Technologies, Inc. K(922037 - System 2000 from MicroMedical Technologies, Inc. K(070085 - Balance Rehabilitation Unit from Medicaa, S.A. Description of the device: The Epley Omniax is a multi-axial positional… | 2007 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 3 companies; a new generation was cleared every 11.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K220231 (Ultrathera Technologies, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K964325.
How does its category compare?
All LXV devicesLXV Apparatus, Vestibular Analysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LXV
1in 2022
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LXV
1in 2010
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 Epley Omniax is intended to assist in the diagnosis and treatment of balance disorders and vertigo, including benign paroxysmal positional vertigo.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071973 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071973: Epley Omniax.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071973
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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