FDA product code · Ophthalmic
HQYSunglasses (Non-Prescription Including Photosensitive)
Product code HQY covers Sunglasses (Non-Prescription Including Photosensitive), a Class I device regulated under 21 CFR 886.5850. FDA has cleared 646 devices in this code. Median review time across the 646 most recent decisions is 64 days. openFDA lists 1 recall record against this code.
Updated · ingest status · JSON
- Class
- Class I
- Regulation
- 21 CFR 886.5850
- Review panel
- Ophthalmic
- Clearances
- 646
What is happening in HQY right now?
HQY (Sunglasses (Non-Prescription Including Photosensitive)): 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 HQY?
FDA has cleared 646 devices under product code HQY since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974860 | NON-PRESCRIPTION SUNGLASSES | Wenzhou Ming Ming Optical Co. , Ltd. | |
| K974852 | NON-PRESCRIPTION SUNGLASSES | Chia Hui Spectacles Mfg. Corp. | |
| K974861 | NON-PRESCRIPTION SUNGLASSES | Wenzhou Hindar Optical Co., Ltd. | |
| K974511 | SUNGLASSES | Sun World Intl., Inc. | |
| K974441 | SUNGLASSES | Hip Shing Fat Co., Ltd. | |
| K974414 | MULTI | Morning Calm Corp. | |
| K973528 | SUNGLASSES | Jeou Jeou Long Industrial Co., Ltd. | |
| K974179 | NON-PRESCRIPTION SUNGLASSES | Taipan Optical Company , Ltd. | |
| K974045 | VENNETO | Amsure Sports, Inc. | |
| K973934 | SUNGLASSES | Elegance Optical Manufactory, Ltd. |
How long does FDA review take for HQY?
The median FDA review time for HQY is 64 days, measured across the 646 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 HQY?
openFDA lists 1 recall record against product code HQY. A recall record covers one firm's corrective action and may span many device lots.
Z-0542-2010TerminatedLuxottica
The lenses made for sunglass frames (Liberty Sport Slam or MaxMorpheus) do not meet the lens thickness specification established by the frame manufacturer. The lens thickness range from 1.0 to 1.9 millimeters instead of the required 2.0 millimeter minimum. There is a potential risk that the lenses could break or disengage from the frame in the event of an impact.
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 HQY?
MAUDE holds 2 adverse-event reports naming product code HQY.
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
Is adverse-event reporting in HQY unusual?
HQY does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history |
2 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
What are the predicate devices in HQY?
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 HQY?
Across the 646 most recent decisions, these applicants filed most often in HQY.
| Applicant | Recent clearances |
|---|---|
| J & B Assoc. | 10 |
| The Orvis Co., Inc. | 9 |
| Blublocker Corp. | 7 |
| Sunny Sunglasses | 6 |
| Ja-Ru, Inc. | 5 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch HQY
Get an email the morning anything changes in HQY — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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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.