FDA product code HQT: Shell, Scleral
HQT is the FDA product code for shell, scleral. It is a Class II device, regulated under 21 CFR 886.3800 and reviewed by the Ophthalmic panel. FDA has cleared 4 510(k) submissions under HQT, from 4 different applicants. The average 510(k) review took 179 days (median 160).
Classification
| Field | Value |
|---|---|
| Device name | Shell, Scleral |
| Device class | Class II |
| Regulation | 21 CFR 886.3800 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| Implant | Yes |
Compare with all 510(k) review times · Search every HQT clearance
Top HQT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Southwest Artificial Eyes, Inc. | 1 | 1997-07-07 |
| Xavier A. Guerra, Ocularist, Inc. | 1 | 1997-07-07 |
| Midwest Eye Laboratories, Inc. | 1 | 1991-08-30 |
| Mira, Inc. | 1 | 1986-03-31 |
Most recent HQT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K970320 | Xavier A. Guerra, Ocularist, Inc. | SCLERAL SHELL | 1997-07-07 | 160 |
| K970327 | Southwest Artificial Eyes, Inc. | SCLERAL SHELL | 1997-07-07 | 160 |
| K904961 | Midwest Eye Laboratories, Inc. | ARTIFICIAL SCLERAL SHELL | 1991-08-30 | 298 |
| K855105 | Mira, Inc. | SIMMONS SHELL | 1986-03-31 | 98 |
Recalls for HQT devices
openFDA lists no recalls for product code HQT.
Frequently asked questions
What is FDA product code HQT?
HQT is the FDA product code for shell, scleral. It is a Class II device, regulated under 21 CFR 886.3800 and reviewed by the Ophthalmic panel.
What device class is HQT?
Class II, regulation 21 CFR 886.3800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HQT?
Across 4 cleared submissions the average was 179 days from receipt to decision (median 160).
Which companies have the most HQT clearances?
Southwest Artificial Eyes, Inc. (1); Xavier A. Guerra, Ocularist, Inc. (1); Midwest Eye Laboratories, Inc. (1); Mira, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HQT
- Run a recall and safety report across every HQT manufacturer
- Watch product code HQT 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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