FDA product code HOQ: Grid, Amsler
HOQ is the FDA product code for grid, amsler. It is a Class I device, regulated under 21 CFR 886.1330 and reviewed by the Ophthalmic panel. FDA has cleared 8 510(k) submissions under HOQ, from 6 different applicants. The average 510(k) review took 154 days (median 117).
Classification
| Field | Value |
|---|---|
| Device name | Grid, Amsler |
| Device class | Class I |
| Regulation | 21 CFR 886.1330 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
510(k) clearances per year for HOQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 83 |
Compare with all 510(k) review times · Search every HOQ clearance
Top HOQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vital Art and Science Incorporated | 2 | 2015-03-20 |
| Wheel Checkers | 2 | 1987-01-20 |
| Oculocare Medical AG | 1 | 2018-06-27 |
| Notal Vision, Inc. | 1 | 2002-03-04 |
| Richmond Products, Inc. | 1 | 1988-01-27 |
1 more applicants have HOQ clearances. See the full list in Caduvo.
Most recent HOQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K180895 | Oculocare Medical AG | Alleye | 2018-06-27 | 83 |
| K143211 | Vital Art and Science Incorporated | myVision Track Model 005 | 2015-03-20 | 130 |
| K121738 | Vital Art and Science Incorporated | MYVISIONTRACK(TM) | 2013-02-22 | 254 |
| K014044 | Notal Vision, Inc. | MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) | 2002-03-04 | 87 |
| K874252 | Richmond Products, Inc. | KREDA DISC | 1988-01-27 | 100 |
Recalls for HOQ devices
openFDA lists no recalls for product code HOQ.
Frequently asked questions
What is FDA product code HOQ?
HOQ is the FDA product code for grid, amsler. It is a Class I device, regulated under 21 CFR 886.1330 and reviewed by the Ophthalmic panel.
What device class is HOQ?
Class I, regulation 21 CFR 886.1330. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HOQ?
Across 8 cleared submissions the average was 154 days from receipt to decision (median 117).
Which companies have the most HOQ clearances?
Vital Art and Science Incorporated (2); Wheel Checkers (2); Oculocare Medical AG (1); Notal Vision, Inc. (1); Richmond Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HOQ
- Run a recall and safety report across every HOQ manufacturer
- Watch product code HOQ 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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