510(k) · Cleared
ClearedVestibular Ocular Reflex Test Equipment (Vorteq)
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 May 31, 1989 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- May 31, 1989
- Review
- 89 days
- Class
- Class U
- Product code
- LXV
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK891008 Vestibular Ocular Reflex Test Equipment (Vorteq)Micromedical Technologies, Inc. · 1989
- Descendant · cites it directly · 4 of its ownK122550 Ics ImpulseGn Otometrics · 2013
- Descendant · 2 generations on · 3 of its ownK151504 ICS ImpulseGn Otometrics · 2015
- Descendant · 3 generations on · 0 of its ownK242198 ICS Dizcovery (1091)Natus Medical Denmark Aps · 2025
- Descendant · 3 generations on · 0 of its ownK242726 Synapsys VHITInventis S.R.L. · 2025
- Descendant · 3 generations on · 0 of its ownK163270 ISEN-Goggles with Data ViewerIsent Tech & Trading Company, Ltd. · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K122550Ics ImpulseGn Otometrics · 2013 · cites it directly4descendants
- K151504ICS ImpulseGn Otometrics · 2015 · 2 generations on3descendants
- K242198ICS Dizcovery (1091)Natus Medical Denmark Aps · 2025 · 3 generations on0descendants
- K242726Synapsys VHITInventis S.R.L. · 2025 · 3 generations on0descendants
- K163270ISEN-Goggles with Data ViewerIsent Tech & Trading Company, Ltd. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K891008 | Vestibular Ocular Reflex Test Equipment (Vorteq) | Micromedical Technologies, Inc. | 1989 | — |
| +1 | K122550 | Ics Impulse | Gn Otometrics | 2013 | — |
| +2 | K151504 | ICS Impulse | Gn Otometrics | 2015 | — |
| +3 | K242198 | ICS Dizcovery (1091) | Natus Medical Denmark Aps | 2025 | — |
| +3 | K242726 | Synapsys VHIT | Inventis S.R.L. | 2025 | — |
| +3 | K163270 | ISEN-Goggles with Data Viewer | Isent Tech & Trading Company, Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2025 | 2 | 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 3.9 · 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
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, K122550 (Gn Otometrics, 2013) has gone furthest, with 4 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/K891008 · printed Nov 4, 2026
Cite this page
510(k) Report. “K891008: Vestibular Ocular Reflex Test Equipment (Vorteq).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K891008
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026