FDA product code · Ophthalmic
HQZFrame, Spectacle
Product code HQZ covers Frame, Spectacle, a Class I device regulated under 21 CFR 886.5842. FDA has cleared 198 devices in this code. Median review time across the 198 most recent decisions is 61 days. openFDA lists 1 recall record against this code.
Updated · ingest status · JSON
- Class
- Class I
- Regulation
- 21 CFR 886.5842
- Review panel
- Ophthalmic
- Clearances
- 198
What is happening in HQZ right now?
HQZ (Frame, Spectacle): nothing changed in the six FDA sources we watch.
Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.
How many devices has FDA cleared in HQZ?
FDA has cleared 198 devices under product code HQZ since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952597 | VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW | Point of View Optical Outlet, Inc. | |
| K944313 | SPECTACLE FRAME | Sun Hing Optical Manufactory , Ltd. | |
| K945770 | OPTICAL FRAMES | Ramada Optics, Inc. | |
| K945392 | SPECTACLE FRAME | Seo Han Corp., Ltd. | |
| K945176 | SPECTACLE FRAME OR EYEGLASS FRAMES | Optipia Trading Co. | |
| K945350 | FRAME, SPECTACLES | Taiwan Eva Industrial Co., Inc. | |
| K945342 | MAG-1 SPECTACLE FRAME | Criss Optical Mfg. Co., Inc. | |
| K945450 | FRAME, SPECTACLE | Kookje Apis Industrial Co. | |
| K945340 | SPECTACLE FRAMES OR EYEGLASS FRAMES | Mi Mun Corp. | |
| K945323 | SPECTACLE FRAME | M.Y. Vision Corp. |
How long does FDA review take for HQZ?
The median FDA review time for HQZ is 61 days, measured across the 198 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in HQZ?
openFDA lists 1 recall record against product code HQZ. A recall record covers one firm's corrective action and may span many device lots.
Z-0541-04TerminatedMagnivision, Inc.
Possibility of eye injury from large temple tags on promotional sale product when customer tries them on in store.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for HQZ?
MAUDE holds 1 adverse-event reports naming product code HQZ.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
What are the predicate devices in HQZ?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in HQZ?
Across the 198 most recent decisions, these applicants filed most often in HQZ.
| Applicant | Recent clearances |
|---|---|
| Australian Optical Co., Inc. | 5 |
| Frontier Novelty, Inc. | 4 |
| South West Intl., Inc. | 4 |
| Roseburg SA | 3 |
| Atlantic Optical Co., Inc. | 2 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch HQZ
Get an email the morning anything changes in HQZ — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Ophthalmic
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.