{
  "code": "HQZ",
  "deviceName": "Frame, Spectacle",
  "deviceClass": "I",
  "regulationNumber": "886.5842",
  "panel": "Ophthalmic",
  "definition": null,
  "submissionTypeId": "4",
  "submissionType": "510(k)",
  "clearances": {
    "total": 198,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 1,
    "last12Months": 0
  },
  "reviewDays": {
    "median": 61,
    "sampleSize": 198
  },
  "recalls": {
    "total": 1,
    "recent": [
      {
        "resNumber": "Z-0541-04",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Magnivision, Inc.",
        "firmAsPublished": "Magnivision, Inc.",
        "reason": "Possibility of eye injury from large temple tags on promotional sale product when customer tries them on in store.",
        "initiated": "2003-05-02"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K952597",
      "deviceName": "VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW",
      "applicant": "Point of View Optical Outlet, Inc.",
      "company": "Point of View Optical Outlet, Inc.",
      "decisionDate": "1995-09-12",
      "dateReceived": "1995-06-06"
    },
    {
      "kNumber": "K944313",
      "deviceName": "SPECTACLE FRAME",
      "applicant": "Sun Hing Optical Manufactory , Ltd.",
      "company": "Sun Hing Optical Manufactory , Ltd.",
      "decisionDate": "1995-03-28",
      "dateReceived": "1994-08-29"
    },
    {
      "kNumber": "K945770",
      "deviceName": "OPTICAL FRAMES",
      "applicant": "Ramada Optics, Inc.",
      "company": "Ramada Optics, Inc.",
      "decisionDate": "1994-12-15",
      "dateReceived": "1994-11-02"
    },
    {
      "kNumber": "K945392",
      "deviceName": "SPECTACLE FRAME",
      "applicant": "Seo Han Corp., Ltd.",
      "company": "Seo Han Corp., Ltd.",
      "decisionDate": "1994-12-15",
      "dateReceived": "1994-11-03"
    },
    {
      "kNumber": "K945176",
      "deviceName": "SPECTACLE FRAME OR EYEGLASS FRAMES",
      "applicant": "Optipia Trading Co.",
      "company": "Optipia Trading Co.",
      "decisionDate": "1994-12-15",
      "dateReceived": "1994-10-24"
    },
    {
      "kNumber": "K945350",
      "deviceName": "FRAME, SPECTACLES",
      "applicant": "Taiwan Eva Industrial Co., Inc.",
      "company": "Taiwan Eva Industrial Co., Inc.",
      "decisionDate": "1994-12-13",
      "dateReceived": "1994-09-14"
    },
    {
      "kNumber": "K945342",
      "deviceName": "MAG-1 SPECTACLE FRAME",
      "applicant": "Criss Optical Mfg. Co., Inc.",
      "company": "Criss Optical Mfg. Co., Inc.",
      "decisionDate": "1994-11-28",
      "dateReceived": "1994-11-01"
    },
    {
      "kNumber": "K945450",
      "deviceName": "FRAME, SPECTACLE",
      "applicant": "Kookje Apis Industrial Co.",
      "company": "Kookje Apis Industrial Co.",
      "decisionDate": "1994-11-22",
      "dateReceived": "1994-11-03"
    },
    {
      "kNumber": "K945340",
      "deviceName": "SPECTACLE FRAMES OR EYEGLASS FRAMES",
      "applicant": "Mi Mun Corp.",
      "company": "Mi Mun Corp.",
      "decisionDate": "1994-11-22",
      "dateReceived": "1994-11-01"
    },
    {
      "kNumber": "K945323",
      "deviceName": "SPECTACLE FRAME",
      "applicant": "M.Y. Vision Corp.",
      "company": "M.Y. Vision Corp.",
      "decisionDate": "1994-11-22",
      "dateReceived": "1994-11-01"
    }
  ],
  "topApplicants": [
    {
      "name": "Australian Optical Co., Inc.",
      "count": 5
    },
    {
      "name": "Frontier Novelty, Inc.",
      "count": 4
    },
    {
      "name": "South West Intl., Inc.",
      "count": 4
    },
    {
      "name": "Roseburg SA",
      "count": 3
    },
    {
      "name": "Atlantic Optical Co., Inc.",
      "count": 2
    }
  ],
  "topCompanies": [
    {
      "name": "Australian Optical Co., Inc.",
      "count": 5,
      "spellings": 1
    },
    {
      "name": "Frontier Novelty, Inc.",
      "count": 4,
      "spellings": 1
    },
    {
      "name": "South West Intl., Inc.",
      "count": 4,
      "spellings": 1
    },
    {
      "name": "Roseburg SA",
      "count": 3,
      "spellings": 1
    },
    {
      "name": "Atlantic Optical Co., Inc.",
      "count": 2,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "HQZ (Frame, Spectacle): 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%3AHQZ"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHQZ"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHQZ"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AHQZ"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AHQZ"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AHQZ"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AHQZ"
    }
  ],
  "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"
}