510(k) · Cleared
ClearedBalance Manager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurocom International, Inc. · KHX Platform, Force-Measuring
Cleared on Aug 4, 1995 after a 225-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Aug 4, 1995
- Review
- 225 days
- Class
- Class I
- Product code
- KHX
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK946229 Balance ManagerNeurocom International, Inc. · 1995
- Descendant · cites it directly · 5 of its ownK070085 Balance Rehabilitation Unit (Bru)Medicaa (Uruguay) S.A. · 2007
- Descendant · 2 generations on · 3 of its ownK071973 Epley OmniaxVesticon · 2008
- Descendant · 3 generations on · 0 of its ownK220231 GyroStimUltrathera Technologies, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK192652 TRVInteracoustics A/S · 2020
- Descendant · 2 generations on · 0 of its ownK082634 Vertigone BPPV GoggleVertigone, Inc. · 2009
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K070085Balance Rehabilitation Unit (Bru)Medicaa (Uruguay) S.A. · 2007 · cites it directly5descendants
- K071973Epley OmniaxVesticon · 2008 · 2 generations on3descendants
- K220231GyroStimUltrathera Technologies, Inc. · 2022 · 3 generations on0descendants
- K192652TRVInteracoustics A/S · 2020 · 3 generations on0descendants
- K082634Vertigone BPPV GoggleVertigone, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946229 | Balance Manager | Neurocom International, Inc. | 1995 | — |
| +1 | K070085 | Balance Rehabilitation Unit (Bru) | Medicaa (Uruguay) S.A. | 2007 | — |
| +2 | K071973 | Epley Omniax | Vesticon | 2008 | — |
| +3 | K220231 | GyroStim | Ultrathera Technologies, Inc. | 2022 | — |
| +3 | K192652 | TRV | Interacoustics A/S | 2020 | — |
| +2 | K082634 | Vertigone BPPV Goggle | Vertigone, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KHX? 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
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
2 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?
- Of its descendants, K070085 (Medicaa (Uruguay) S.A., 2007) has gone furthest, with 5 descendants of its own.
How does its category compare?
All KHX devicesKHX Platform, Force-Measuring: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KHX
FDA has decided no KHX device since 2007.
Median 510(k) review, days · KHX
Too few KHX 510(k)s in any year since 2007 to give a median.
Recalls per year · KHX
No recall names KHX since 2007.
Adverse event reports per year · KHX
1in 2019
MAUDE reports naming product code KHX, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K946229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K946229: Balance Manager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K946229
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026