FDA product code HQZ: Frame, Spectacle
HQZ is the FDA product code for frame, spectacle. It is a Class I device, regulated under 21 CFR 886.5842 and reviewed by the Ophthalmic panel. FDA has cleared 198 510(k) submissions under HQZ, from 179 different applicants. The average 510(k) review took 78 days (median 61). FDA has posted 1 recall for HQZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Frame, Spectacle |
| Device class | Class I |
| Regulation | 21 CFR 886.5842 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HQZ clearance
Top HQZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Australian Optical Co., Inc. | 5 | 1994-09-14 |
| Frontier Novelty, Inc. | 4 | 1994-04-12 |
| South West Intl., Inc. | 4 | 1986-07-11 |
| Roseburg SA | 3 | 1987-05-29 |
| Oliver Peoples, Inc. | 2 | 1994-07-12 |
174 more applicants have HQZ clearances. See the full list in Caduvo.
Most recent HQZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K952597 | Point of View Optical Outlet, Inc. | VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW | 1995-09-12 | 98 |
| K944313 | Sun Hing Optical Manufactory , Ltd. | SPECTACLE FRAME | 1995-03-28 | 211 |
| K945176 | Optipia Trading Co. | SPECTACLE FRAME OR EYEGLASS FRAMES | 1994-12-15 | 52 |
| K945770 | Ramada Optics, Inc. | OPTICAL FRAMES | 1994-12-15 | 43 |
| K945392 | Seo Han Corp., Ltd. | SPECTACLE FRAME | 1994-12-15 | 42 |
Recalls for HQZ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2003-05-02.
Frequently asked questions
What is FDA product code HQZ?
HQZ is the FDA product code for frame, spectacle. It is a Class I device, regulated under 21 CFR 886.5842 and reviewed by the Ophthalmic panel.
What device class is HQZ?
Class I, regulation 21 CFR 886.5842. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HQZ?
Across 198 cleared submissions the average was 78 days from receipt to decision (median 61).
Which companies have the most HQZ clearances?
Australian Optical Co., Inc. (5); Frontier Novelty, Inc. (4); South West Intl., Inc. (4); Roseburg SA (3); Oliver Peoples, Inc. (2).
Have HQZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2003-05-02.
Next steps
- Run an FDA pathway report with predicate devices for product code HQZ
- Run a recall and safety report across every HQZ manufacturer
- Watch product code HQZ 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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