FDA product code LXV: Apparatus, Vestibular Analysis
LXV is the FDA product code for apparatus, vestibular analysis. It is a Unclassified device, reviewed by the Ear, Nose and Throat panel. FDA has cleared 22 510(k) submissions under LXV, 1 in the last five years, from 19 different applicants. The average 510(k) review took 154 days (median 118). FDA has posted 2 recalls for LXV devices.
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Vestibular Analysis |
| Device class | Unclassified |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for LXV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 123 |
| 2019 | 2 | 224 |
| 2020 | 2 | 204 |
| 2022 | 1 | 90 |
Compare with all 510(k) review times · Search every LXV clearance
Top LXV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Interacoustics A/S | 3 | 2020-08-12 |
| Micromedical Technologies, Inc. | 2 | 1992-10-26 |
| Ultrathera Technologies, Inc. | 1 | 2022-04-27 |
| Quadrant Biosciences | 1 | 2019-10-22 |
| Upright Science, Inc. | 1 | 2019-08-16 |
14 more applicants have LXV clearances. See the full list in Caduvo.
Most recent LXV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220231 | Ultrathera Technologies, Inc. | GyroStim | 2022-04-27 | 90 |
| K200529 | Interacoustics A/S | Orion | 2020-08-12 | 163 |
| K192652 | Interacoustics A/S | TRV | 2020-05-27 | 246 |
| K183661 | Quadrant Biosciences | ClearEdge Balance System | 2019-10-22 | 299 |
| K190735 | Upright Science, Inc. | EQ Balance | 2019-08-16 | 148 |
Recalls for LXV devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-07-24.
Frequently asked questions
What is FDA product code LXV?
LXV is the FDA product code for apparatus, vestibular analysis. It is a Unclassified device, reviewed by the Ear, Nose and Throat panel.
What device class is LXV?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LXV?
Across 22 cleared submissions the average was 154 days from receipt to decision (median 118).
Which companies have the most LXV clearances?
Interacoustics A/S (3); Micromedical Technologies, Inc. (2); Ultrathera Technologies, Inc. (1); Quadrant Biosciences (1); Upright Science, Inc. (1).
Have LXV devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2009-07-24.
Next steps
- Run an FDA pathway report with predicate devices for product code LXV
- Run a recall and safety report across every LXV manufacturer
- Watch product code LXV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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