{
  "code": "MQL",
  "deviceName": "Media, Reproductive",
  "deviceClass": "II",
  "regulationNumber": "884.6180",
  "panel": "Obstetrics/Gynecology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 259,
    "last12Months": 5
  },
  "adverseEvents": {
    "total": 10,
    "last12Months": 2
  },
  "reviewDays": {
    "median": 128,
    "sampleSize": 259
  },
  "recalls": {
    "total": 15,
    "recent": [
      {
        "resNumber": "Z-3296-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "CooperSurgical, Inc.",
        "firmAsPublished": "CooperSurgical, Inc.",
        "reason": "Low concentration of sodium pyruvate in the wash could compromise gamete development",
        "initiated": "2024-02-16"
      },
      {
        "resNumber": "Z-3297-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "CooperSurgical, Inc.",
        "firmAsPublished": "CooperSurgical, Inc.",
        "reason": "Low concentration of sodium pyruvate in the wash could compromise gamete development",
        "initiated": "2024-02-16"
      },
      {
        "resNumber": "Z-3298-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "CooperSurgical, Inc.",
        "firmAsPublished": "CooperSurgical, Inc.",
        "reason": "Low concentration of sodium pyruvate in the wash could compromise gamete development",
        "initiated": "2024-02-16"
      },
      {
        "resNumber": "Z-1089-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "CooperSurgical, Inc.",
        "firmAsPublished": "CooperSurgical, Inc.",
        "reason": "The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage.",
        "initiated": "2023-12-20"
      },
      {
        "resNumber": "Z-0998-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Fujifilm Irvine Scientific, Inc.",
        "firmAsPublished": "Fujifilm Irvine Scientific, Inc.",
        "reason": "The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686, Shelf Life: 31 December 2024) but incorrectly may contain lower layer (Lot number 9925811106, Shelf Life: 30 November 2023).",
        "initiated": "2023-11-02"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K260248",
      "deviceName": "Ultra-Fast Warm",
      "applicant": "Kitazato Corporation",
      "company": "Kitazato Corporation",
      "decisionDate": "2026-04-28",
      "dateReceived": "2026-01-27"
    },
    {
      "kNumber": "K252672",
      "deviceName": "CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)",
      "applicant": "Casebioscience, Inc.",
      "company": "Casebioscience, Inc.",
      "decisionDate": "2026-02-20",
      "dateReceived": "2025-08-25"
    },
    {
      "kNumber": "K250445",
      "deviceName": "Fast Warm - NX",
      "applicant": "Fujifilm Irvine Scientific",
      "company": "Fujifilm Irvine Scientific, Inc.",
      "decisionDate": "2025-09-12",
      "dateReceived": "2025-02-14"
    },
    {
      "kNumber": "K251637",
      "deviceName": "Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])",
      "applicant": "Donnevie Medical Technology (Shanghai) Co. , Ltd.",
      "company": "Donnevie Medical Technology (Shanghai) Co. , Ltd.",
      "decisionDate": "2025-08-27",
      "dateReceived": "2025-05-29"
    },
    {
      "kNumber": "K251305",
      "deviceName": "Ultra-Fast Vitri; Ultra-Fast Warm",
      "applicant": "Kitazato Corporation",
      "company": "Kitazato Corporation",
      "decisionDate": "2025-08-26",
      "dateReceived": "2025-04-28"
    },
    {
      "kNumber": "K242640",
      "deviceName": "FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin",
      "applicant": "Fertipro NV",
      "company": "Fertipro NV",
      "decisionDate": "2025-05-30",
      "dateReceived": "2024-09-03"
    },
    {
      "kNumber": "K242561",
      "deviceName": "Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)",
      "applicant": "Donnevie Medical Technology (Shanghai) Co. , Ltd.",
      "company": "Donnevie Medical Technology (Shanghai) Co. , Ltd.",
      "decisionDate": "2025-04-10",
      "dateReceived": "2024-08-28"
    },
    {
      "kNumber": "K242089",
      "deviceName": "Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)",
      "applicant": "Jiangsu Ruifuda Medical Device Co., Ltd.",
      "company": "Jiangsu Ruifuda Medical Device Co., Ltd.",
      "decisionDate": "2025-04-10",
      "dateReceived": "2024-07-17"
    },
    {
      "kNumber": "K242107",
      "deviceName": "CaseMONO™ Culture  (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)",
      "applicant": "Casebioscience, Inc.",
      "company": "Casebioscience, Inc.",
      "decisionDate": "2025-03-21",
      "dateReceived": "2024-07-18"
    },
    {
      "kNumber": "K241833",
      "deviceName": "V-GRAD",
      "applicant": "Vitromed GmbH",
      "company": "Vitromed GmbH",
      "decisionDate": "2025-03-21",
      "dateReceived": "2024-06-25"
    }
  ],
  "topApplicants": [
    {
      "name": "Irvine Scientific Sales Co., Inc.",
      "count": 36
    },
    {
      "name": "Vitrolife Sweden AB",
      "count": 28
    },
    {
      "name": "Medicult A/S",
      "count": 26
    },
    {
      "name": "<Genx> Intl., Inc.",
      "count": 15
    },
    {
      "name": "Nidacon International AB",
      "count": 11
    }
  ],
  "topCompanies": [
    {
      "name": "Irvine Scientific Sales Co., Inc.",
      "count": 36,
      "spellings": 1
    },
    {
      "name": "Vitrolife Sweden AB",
      "count": 28,
      "spellings": 1
    },
    {
      "name": "Medicult A/S",
      "count": 26,
      "spellings": 1
    },
    {
      "name": "<Genx> Intl., Inc.",
      "count": 20,
      "spellings": 2
    },
    {
      "name": "Nidacon International AB",
      "count": 11,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "MQL (Media, Reproductive): 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%3AMQL"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMQL"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMQL"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AMQL"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AMQL"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AMQL"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AMQL"
    }
  ],
  "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": "2026-08-11T13:51:45.746Z"
}