FDA product code MXK: Device, Analysis, Anterior Segment
MXK is the FDA product code for device, analysis, anterior segment. It is a Class II device, regulated under 21 CFR 886.1850 and reviewed by the Ophthalmic panel. FDA has cleared 23 510(k) submissions under MXK, 5 in the last five years, from 15 different applicants. The average 510(k) review took 198 days (median 193); 342 days on average over the last three years. FDA has posted 7 recalls for MXK devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Analysis, Anterior Segment |
| Device class | Class II |
| Regulation | 21 CFR 886.1850 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MXK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 165 |
| 2020 | 1 | 120 |
| 2021 | 1 | 287 |
| 2022 | 1 | 258 |
| 2023 | 1 | 276 |
| 2024 | 1 | 613 |
| 2025 | 1 | 142 |
| 2026 | 1 | 270 |
Compare with all 510(k) review times · Search every MXK clearance
Top MXK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Oculus Optikgerate GmbH | 5 | 2020-10-21 |
| Oculus Optikgeräte GmbH | 2 | 2026-03-13 |
| Visia Imaging S.R.L. | 2 | 2023-06-29 |
| Santec Corporation | 2 | 2019-05-16 |
| Heidelberg Engineering | 2 | 2006-01-13 |
10 more applicants have MXK clearances. See the full list in Caduvo.
Most recent MXK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251848 | Oculus Optikgeräte GmbH | Pentacam® Cornea OCT | 2026-03-13 | 270 |
| K252348 | Tomey Corporation | Tomey Optical Biometer OA-2000 (OA-2000) | 2025-12-18 | 142 |
| K223700 | Intelon Optics, Inc. | BOSS | 2024-08-16 | 613 |
| K222933 | Visia Imaging S.R.L. | MYAH | 2023-06-29 | 276 |
| K211868 | Visia Imaging S.R.L. | MYAH | 2022-03-01 | 258 |
Recalls for MXK devices
7 product recalls in 3 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2023-08-08.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2022 | 3 |
| 2023 | 3 |
Frequently asked questions
What is FDA product code MXK?
MXK is the FDA product code for device, analysis, anterior segment. It is a Class II device, regulated under 21 CFR 886.1850 and reviewed by the Ophthalmic panel.
What device class is MXK?
Class II, regulation 21 CFR 886.1850. Typical premarket route: 510(k).
How long does a 510(k) take for product code MXK?
Across 23 cleared submissions the average was 198 days from receipt to decision (median 193).
Which companies have the most MXK clearances?
Oculus Optikgerate GmbH (5); Oculus Optikgeräte GmbH (2); Visia Imaging S.R.L. (2); Santec Corporation (2); Heidelberg Engineering (2).
Have MXK devices been recalled?
Yes: 7 product recalls across 3 recall events; the most recent began 2023-08-08.
Next steps
- Run an FDA pathway report with predicate devices for product code MXK
- Run a recall and safety report across every MXK manufacturer
- Watch product code MXK 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.
All Ophthalmic product codes · FDA product code lookup · 510(k) database search · 510(k) review times