510(k) · Cleared
ClearedGyroStim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultrathera Technologies, Inc. · LXV Apparatus, Vestibular Analysis
Cleared on Apr 27, 2022 as substantially equivalent to K071973 (Vesticon, 2008) after a 90-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Apr 27, 2022
- Review
- 90 days
- Class
- Class U
- Product code
- LXV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K946229 (1995). 6 ancestors in all, the oldest K863424 (1987). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K946229 | Balance Manager | Neurocom International, Inc. | 1995 | — |
| −2 | K070085 | Balance Rehabilitation Unit (Bru) | Medicaa (Uruguay) S.A. | 2007 | — |
| −1 | K071973 | Epley Omniax | Vesticon | 2008 | — |
| 0 (this device) | K220231 | GyroStim | Ultrathera Technologies, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 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 K192652 TRVscore 0.0 · 3 generations · no Class I recall
- #2 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K071973 | Epley OmniaxSummary page 4…LXV 510(k) Number K220231 Review Panel Ear, Nose, and Throat (ENT) Devices 3. Predicate Device Vesticon Epley OmniaxTM, 510(k) # K071973 4. Device Description GyroStim is an AC powered computer-controlled multi-axial positional and rotational chair.… | 2008 |
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 27 years and passes through 4 companies; a new generation was cleared every 11.6 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K071973.
How does its category compare?
All LXV devicesLXV Apparatus, Vestibular Analysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 GyroStim is intended to assist in the treatment of balance disorders and vestibular dysfunction in adult patients, age 18 and older, up to 4001b. It is intended to be used by a trained medical professional as prescribed by physician in a clinical environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220231: GyroStim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220231
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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