510(k) · Cleared
ClearedNydiag 200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interacoustics A/S · LXV Apparatus, Vestibular Analysis
Cleared on Dec 23, 2010 as substantially equivalent to K922037 (Micromedical Technologies, Inc., 1992) after a 125-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Dec 23, 2010
- Review
- 125 days
- Class
- Class U
- Product code
- LXV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922037 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK922037 System 2000, Rotational Vestibular ChairMicromedical Technologies, Inc. · 1992
- This deviceK102364 Nydiag 200Interacoustics A/S · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922037 | System 2000, Rotational Vestibular Chair | Micromedical Technologies, Inc. | 1992 | — |
| 0 (this device) | K102364 | Nydiag 200 | Interacoustics A/S | 2010 | — |
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? (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 |
|---|---|---|---|
| * | K922037 | System 2000, Rotational Vestibular ChairSummary page 1…2000 ROTATIONAL VESTIBULAR CHAIR Manufacturer Micromedical Technologies, Inc 510(k) No. K922037 Date Cleared 10/26/1992 Device Description The Nydiag 200 is a rotation chair, including a chair unit an… | 1992 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K922037.
How does its category compare?
All LXV devicesLXV Apparatus, Vestibular Analysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Nydiag 200 rotary chair is an optional accessory for the Interacoustics eye movement recording systems. The rotary chair is used to elicit Vestibulo-Ocular Reflexes in patients aged 2 years or older who weigh less than 135 kg / 300 lbs who are being tested for bilateral or unilateral lesions in the peripheral vestibular organs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102364 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102364: Nydiag 200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102364
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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