FDA product code HMQ: Marker, Sclera
HMQ is the FDA product code for marker, sclera. It is a Class I device, regulated under 21 CFR 886.4570 and reviewed by the Ophthalmic panel. Devices under HMQ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for HMQ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Marker, Sclera |
| Device class | Class I |
| Regulation | 21 CFR 886.4570 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for HMQ devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-12-16.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code HMQ?
HMQ is the FDA product code for marker, sclera. It is a Class I device, regulated under 21 CFR 886.4570 and reviewed by the Ophthalmic panel.
What device class is HMQ?
Class I, regulation 21 CFR 886.4570. Typical premarket route: 510(k) exempt.
Have HMQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-12-16.
Next steps
- Run an FDA pathway report with predicate devices for product code HMQ
- Run a recall and safety report across every HMQ manufacturer
- Watch product code HMQ 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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