FDA product code HMC: Monitor, Eye Movement, Diagnostic
HMC is the FDA product code for monitor, eye movement, diagnostic. It is a Class II device, regulated under 21 CFR 886.1510 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under HMC. The average 510(k) review took 556 days (median 556).
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Eye Movement, Diagnostic |
| Device class | Class II |
| Regulation | 21 CFR 886.1510 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Top HMC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthomet, Inc. | 1 | 1994-10-14 |
Most recent HMC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K931678 | Orthomet, Inc. | ORTHOMET LHMC FEMORAL STEM | 1994-10-14 | 556 |
Recalls for HMC devices
openFDA lists no recalls for product code HMC.
Frequently asked questions
What is FDA product code HMC?
HMC is the FDA product code for monitor, eye movement, diagnostic. It is a Class II device, regulated under 21 CFR 886.1510 and reviewed by the Ophthalmic panel.
What device class is HMC?
Class II, regulation 21 CFR 886.1510. Typical premarket route: 510(k).
How long does a 510(k) take for product code HMC?
Across 1 cleared submissions the average was 556 days from receipt to decision (median 556).
Which companies have the most HMC clearances?
Orthomet, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HMC
- Run a recall and safety report across every HMC manufacturer
- Watch product code HMC 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.