510(k) · Cleared
ClearedSystem 2000, Rotational Vestibular Chair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micromedical Technologies, Inc. · LXV Apparatus, Vestibular Analysis
Cleared on Oct 26, 1992 after a 178-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Oct 26, 1992
- Review
- 178 days
- Class
- Class U
- Product code
- LXV
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK922037 System 2000, Rotational Vestibular ChairMicromedical Technologies, Inc. · 1992
- Descendant · cites it directly · 3 of its ownK071973 Epley OmniaxVesticon · 2008
- Descendant · 2 generations on · 0 of its ownK220231 GyroStimUltrathera Technologies, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK200529 OrionInteracoustics A/S · 2020
- Descendant · 2 generations on · 0 of its ownK192652 TRVInteracoustics A/S · 2020
- Descendant · cites it directly · 0 of its ownK102364 Nydiag 200Interacoustics A/S · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K071973Epley OmniaxVesticon · 2008 · cites it directly3descendants
- K220231GyroStimUltrathera Technologies, Inc. · 2022 · 2 generations on0descendants
- K200529OrionInteracoustics A/S · 2020 · cites it directly0descendants
- K192652TRVInteracoustics A/S · 2020 · 2 generations on0descendants
- K102364Nydiag 200Interacoustics A/S · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922037 | System 2000, Rotational Vestibular Chair | Micromedical Technologies, Inc. | 1992 | — |
| +1 | K071973 | Epley Omniax | Vesticon | 2008 | — |
| +2 | K220231 | GyroStim | Ultrathera Technologies, Inc. | 2022 | — |
| +1 | K200529 | Orion | Interacoustics A/S | 2020 | — |
| +2 | K192652 | TRV | Interacoustics A/S | 2020 | — |
| +1 | K102364 | Nydiag 200 | Interacoustics A/S | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2020 | 2 | 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
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?
- Of its descendants, K071973 (Vesticon, 2008) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LXV devicesLXV Apparatus, Vestibular Analysis: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K922037 · printed Nov 5, 2026
Cite this page
510(k) Report. “K922037: System 2000, Rotational Vestibular Chair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K922037
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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