{
  "code": "HQY",
  "deviceName": "Sunglasses (Non-Prescription Including Photosensitive)",
  "deviceClass": "I",
  "regulationNumber": "886.5850",
  "panel": "Ophthalmic",
  "definition": null,
  "submissionTypeId": "4",
  "submissionType": "510(k)",
  "clearances": {
    "total": 646,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 2,
    "last12Months": 0
  },
  "reviewDays": {
    "median": 64,
    "sampleSize": 646
  },
  "recalls": {
    "total": 1,
    "recent": [
      {
        "resNumber": "Z-0542-2010",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Luxottica",
        "firmAsPublished": "Luxottica",
        "reason": "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.",
        "initiated": "2009-11-24"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K974860",
      "deviceName": "NON-PRESCRIPTION SUNGLASSES",
      "applicant": "Wenzhou Ming Ming Optical Co. , Ltd.",
      "company": "Wenzhou Ming Ming Optical Co. , Ltd.",
      "decisionDate": "1998-01-30",
      "dateReceived": "1997-12-29"
    },
    {
      "kNumber": "K974852",
      "deviceName": "NON-PRESCRIPTION SUNGLASSES",
      "applicant": "Chia Hui Spectacles Mfg. Corp.",
      "company": "Chia Hui Spectacles Mfg. Corp.",
      "decisionDate": "1998-01-30",
      "dateReceived": "1997-12-29"
    },
    {
      "kNumber": "K974861",
      "deviceName": "NON-PRESCRIPTION SUNGLASSES",
      "applicant": "Wenzhou Hindar Optical Co., Ltd.",
      "company": "Wenzhou Hindar Optical Co., Ltd.",
      "decisionDate": "1998-01-27",
      "dateReceived": "1997-12-29"
    },
    {
      "kNumber": "K974511",
      "deviceName": "SUNGLASSES",
      "applicant": "Sun World Intl., Inc.",
      "company": "Sun World Intl., Inc.",
      "decisionDate": "1998-01-12",
      "dateReceived": "1997-12-01"
    },
    {
      "kNumber": "K974441",
      "deviceName": "SUNGLASSES",
      "applicant": "Hip Shing Fat Co., Ltd.",
      "company": "Hip Shing Fat Co., Ltd.",
      "decisionDate": "1998-01-09",
      "dateReceived": "1997-11-25"
    },
    {
      "kNumber": "K974414",
      "deviceName": "MULTI",
      "applicant": "Morning Calm Corp.",
      "company": "Morning Calm Corp.",
      "decisionDate": "1997-12-08",
      "dateReceived": "1997-11-24"
    },
    {
      "kNumber": "K973528",
      "deviceName": "SUNGLASSES",
      "applicant": "Jeou Jeou Long Industrial Co., Ltd.",
      "company": "Jeou Jeou Long Industrial Co., Ltd.",
      "decisionDate": "1997-12-08",
      "dateReceived": "1997-09-17"
    },
    {
      "kNumber": "K974179",
      "deviceName": "NON-PRESCRIPTION SUNGLASSES",
      "applicant": "Taipan Optical Company , Ltd.",
      "company": "Taipan Optical Company , Ltd.",
      "decisionDate": "1997-12-01",
      "dateReceived": "1997-11-06"
    },
    {
      "kNumber": "K974045",
      "deviceName": "VENNETO",
      "applicant": "Amsure Sports, Inc.",
      "company": "Amsure Sports, Inc.",
      "decisionDate": "1997-11-20",
      "dateReceived": "1997-10-24"
    },
    {
      "kNumber": "K973934",
      "deviceName": "SUNGLASSES",
      "applicant": "Elegance Optical Manufactory, Ltd.",
      "company": "Elegance Optical Manufactory, Ltd.",
      "decisionDate": "1997-11-18",
      "dateReceived": "1997-10-15"
    }
  ],
  "topApplicants": [
    {
      "name": "J & B Assoc.",
      "count": 10
    },
    {
      "name": "The Orvis Co., Inc.",
      "count": 9
    },
    {
      "name": "Blublocker Corp.",
      "count": 7
    },
    {
      "name": "Sunny Sunglasses",
      "count": 6
    },
    {
      "name": "Ja-Ru, Inc.",
      "count": 5
    }
  ],
  "topCompanies": [
    {
      "name": "J & B Assoc.",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "The Orvis Co., Inc.",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Blublocker Corp.",
      "count": 7,
      "spellings": 1
    },
    {
      "name": "Sunny Sunglasses",
      "count": 6,
      "spellings": 1
    },
    {
      "name": "Ja-Ru, Inc.",
      "count": 5,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2024-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "HQY (Sunglasses (Non-Prescription Including Photosensitive)): nothing changed in the six FDA sources we watch.",
    "severity": 1,
    "factors": [],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3AHQY"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHQY"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHQY"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AHQY"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AHQY"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AHQY"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AHQY"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.709Z"
}