FDA product code HQH: Eye, Artificial, Non-Custom
HQH is the FDA product code for eye, artificial, non-custom. It is a Class I device, regulated under 21 CFR 886.3200 and reviewed by the Ophthalmic panel. FDA has cleared 6 510(k) submissions under HQH, from 6 different applicants. The average 510(k) review took 133 days (median 98).
Classification
| Field | Value |
|---|---|
| Device name | Eye, Artificial, Non-Custom |
| Device class | Class I |
| Regulation | 21 CFR 886.3200 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HQH clearance
Top HQH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Robert B. Scott Ocularists of Florida, Inc. | 1 | 1995-06-26 |
| Daniel T Acosta | 1 | 1995-05-30 |
| Frank Tanaka, Ocularist, Inc. | 1 | 1995-03-22 |
| Nissel , Ltd. | 1 | 1992-09-02 |
| Midwest Eye Laboratories, Inc. | 1 | 1991-08-30 |
1 more applicants have HQH clearances. See the full list in Caduvo.
Most recent HQH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K952538 | Robert B. Scott Ocularists of Florida, Inc. | ROBERT B. SCOTT PLASTIC ARTIFICAL | 1995-06-26 | 26 |
| K945270 | Daniel T Acosta | CUSTOM ARTIFICIAL HUMAN EYES | 1995-05-30 | 214 |
| K946226 | Frank Tanaka, Ocularist, Inc. | CUSTOM OCULAR PROSTHESIS | 1995-03-22 | 90 |
| K923167 | Nissel , Ltd. | THE NISSEL ARTIFICIAL EYE | 1992-09-02 | 65 |
| K904962 | Midwest Eye Laboratories, Inc. | EYE ARTIFICIAL CUSTOM | 1991-08-30 | 298 |
Recalls for HQH devices
openFDA lists no recalls for product code HQH.
Frequently asked questions
What is FDA product code HQH?
HQH is the FDA product code for eye, artificial, non-custom. It is a Class I device, regulated under 21 CFR 886.3200 and reviewed by the Ophthalmic panel.
What device class is HQH?
Class I, regulation 21 CFR 886.3200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HQH?
Across 6 cleared submissions the average was 133 days from receipt to decision (median 98).
Which companies have the most HQH clearances?
Robert B. Scott Ocularists of Florida, Inc. (1); Daniel T Acosta (1); Frank Tanaka, Ocularist, Inc. (1); Nissel , Ltd. (1); Midwest Eye Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HQH
- Run a recall and safety report across every HQH manufacturer
- Watch product code HQH 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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