{
  "code": "HGX",
  "deviceName": "Pump, Breast, Powered",
  "deviceClass": "II",
  "regulationNumber": "884.5160",
  "panel": "Obstetrics/Gynecology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 248,
    "last12Months": 43
  },
  "adverseEvents": {
    "total": 330,
    "last12Months": 21
  },
  "reviewDays": {
    "median": 145,
    "sampleSize": 248
  },
  "recalls": {
    "total": 8,
    "recent": [
      {
        "resNumber": "Z-0616-2018",
        "status": "Open, Classified",
        "recallClass": "Class III",
        "firm": "Ameda, Inc.",
        "firmAsPublished": "AMEDA, INC.",
        "reason": "Two specific lots was incorrectly manufactured containing a UK power adapter.",
        "initiated": "2017-07-10"
      },
      {
        "resNumber": "Z-1336-2014",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Energizer Personal Care",
        "firmAsPublished": "Energizer Personal Care",
        "reason": "Some of the power adapters outer casings may become loose and separate, resulting in a potential for electric shock.",
        "initiated": "2014-03-18"
      },
      {
        "resNumber": "Z-1224-2011",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Medela Inc",
        "firmAsPublished": "Medela Inc",
        "reason": "The performance of the pumps may be compromised due to the potentiometer used on the circuit board.  Affected pumps may not turn on, may turn off on its own, may reduce or lose suction during the pumping process, or may make a clicking noise.",
        "initiated": "2011-01-10"
      },
      {
        "resNumber": "Z-2483-2010",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Medela Inc",
        "firmAsPublished": "Medela Inc",
        "reason": "The product sterility may be compromised due to possible pinholes in the rigid tray of the package.",
        "initiated": "2010-08-06"
      },
      {
        "resNumber": "Z-2484-2010",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Medela Inc",
        "firmAsPublished": "Medela Inc",
        "reason": "The product sterility may be compromised due to possible pinholes in the rigid tray of the package.",
        "initiated": "2010-08-06"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K260259",
      "deviceName": "DiscreetDuo™ Flow Wearable Breast Pump (Model S3)",
      "applicant": "Shenzhen TPH Technology Co., Ltd.",
      "company": "Shenzhen TPH Technology Co., Ltd.",
      "decisionDate": "2026-07-24",
      "dateReceived": "2026-01-28"
    },
    {
      "kNumber": "K261199",
      "deviceName": "Wearable Breast Pump (Model S32A)",
      "applicant": "Shenzhen TPH Technology Co., Ltd.",
      "company": "Shenzhen TPH Technology Co., Ltd.",
      "decisionDate": "2026-07-13",
      "dateReceived": "2026-04-13"
    },
    {
      "kNumber": "K250070",
      "deviceName": "Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)",
      "applicant": "Shenzhen Changkun Technology Co., Ltd.",
      "company": "Shenzhen Changkun Technology Co., Ltd.",
      "decisionDate": "2026-06-26",
      "dateReceived": "2025-01-10"
    },
    {
      "kNumber": "K261025",
      "deviceName": "Wearable breast pump (QY-101, QY-102, QY-108)",
      "applicant": "Shenzhen Qinyi Electronic Technology Co., Ltd.",
      "company": "Shenzhen Qinyi Electronic Technology Co., Ltd.",
      "decisionDate": "2026-06-25",
      "dateReceived": "2026-03-30"
    },
    {
      "kNumber": "K254254",
      "deviceName": "Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)",
      "applicant": "Shenzhen Root Innovation Technology Co., Ltd.",
      "company": "Shenzhen Root Innovation Technology Co., , Ltd.",
      "decisionDate": "2026-06-18",
      "dateReceived": "2025-12-29"
    },
    {
      "kNumber": "K260538",
      "deviceName": "Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )",
      "applicant": "Shenzhen Root Innovation Technology Co., Ltd.",
      "company": "Shenzhen Root Innovation Technology Co., , Ltd.",
      "decisionDate": "2026-06-17",
      "dateReceived": "2026-02-17"
    },
    {
      "kNumber": "K260346",
      "deviceName": "Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)",
      "applicant": "Polybell (Guangzhou) Limited",
      "company": "Polybell (Guangzhou) Limited",
      "decisionDate": "2026-06-12",
      "dateReceived": "2026-02-03"
    },
    {
      "kNumber": "K250129",
      "deviceName": "AViTA Breast Pump",
      "applicant": "Avita Corporation",
      "company": "Avita Corporation",
      "decisionDate": "2026-06-11",
      "dateReceived": "2025-01-17"
    },
    {
      "kNumber": "K260864",
      "deviceName": "Mother's Nature W1 Warming Wearable Breast Pump",
      "applicant": "Shenzhen TPH Technology Co., Ltd.",
      "company": "Shenzhen TPH Technology Co., Ltd.",
      "decisionDate": "2026-06-09",
      "dateReceived": "2026-03-17"
    },
    {
      "kNumber": "K260956",
      "deviceName": "Spectra Platinum Mini",
      "applicant": "Uzinmedicare Co., Ltd.",
      "company": "Uzinmedicare Co., Ltd.",
      "decisionDate": "2026-06-04",
      "dateReceived": "2026-03-23"
    }
  ],
  "topApplicants": [
    {
      "name": "Shenzhen TPH Technology Co., Ltd.",
      "count": 23
    },
    {
      "name": "Shenzhen Root Innovation Technology Co., Ltd.",
      "count": 10
    },
    {
      "name": "Medela, Inc.",
      "count": 7
    },
    {
      "name": "Medela, LLC",
      "count": 7
    },
    {
      "name": "Evenflo Company, Inc.",
      "count": 6
    }
  ],
  "topCompanies": [
    {
      "name": "Shenzhen TPH Technology Co., Ltd.",
      "count": 23,
      "spellings": 1
    },
    {
      "name": "Medela Inc",
      "count": 19,
      "spellings": 3
    },
    {
      "name": "Uzinmedicare Co., Ltd.",
      "count": 12,
      "spellings": 3
    },
    {
      "name": "Shenzhen Root Innovation Technology Co., , Ltd.",
      "count": 11,
      "spellings": 2
    },
    {
      "name": "Evenflo Company, Inc.",
      "count": 9,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "Shenzhen Qinyi Electronic Technology Co., Ltd.",
      "since": "2026-06-25",
      "kNumber": "K261025"
    },
    {
      "name": "Polybell (Guangzhou) Limited",
      "since": "2026-06-12",
      "kNumber": "K260346"
    },
    {
      "name": "Avita Corporation",
      "since": "2026-06-11",
      "kNumber": "K250129"
    },
    {
      "name": "Linhejiacheng (Shenzhen) E-Commerce Co., Ltd.",
      "since": "2025-12-23",
      "kNumber": "K253072"
    },
    {
      "name": "Anker Innovations Limited",
      "since": "2025-08-11",
      "kNumber": "K250207"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 25,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 22,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 17,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 7,
        "expectedLow": 0,
        "expectedHigh": 17.700011673577723,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 14.608470050339498,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 9,
        "expectedLow": 0,
        "expectedHigh": 15.64639395795026,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 7,
        "expectedLow": 0,
        "expectedHigh": 17.30715929244326,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 11,
        "expectedLow": 0,
        "expectedHigh": 14.734231507572025,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 16.943351911309403,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 7,
        "expectedLow": 2.5255040147874714,
        "expectedHigh": 18.025154247993708,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 6,
        "expectedLow": 1.0973453592580882,
        "expectedHigh": 12.923032168942203,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 5,
        "expectedLow": 0.7817472451301296,
        "expectedHigh": 13.250964090105406,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 2,
        "expectedLow": 0.12912571675793413,
        "expectedHigh": 12.685908619921166,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 1,
        "expectedLow": 0,
        "expectedHigh": 10.802575085314523,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 11.514826592168719,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 13.118863968840314,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 13,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "HGX (Pump, Breast, Powered) has two findings, most consequential first. 5 first-time filers in the last 12 months, including Shenzhen Qinyi Electronic Technology Co., Ltd. and Polybell (Guangzhou) Limited (K261025, K260346, K250129, K253072, K250207). The code is crowded, scoring 91 of 100 — 102 companies hold a clearance here and 43 arrived in the last 12 months (HGX:crowding).",
    "severity": 45,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "5 first-time filers in the last 12 months, including Shenzhen Qinyi Electronic Technology Co., Ltd. and Polybell (Guangzhou) Limited",
        "recordIds": [
          "K261025",
          "K260346",
          "K250129",
          "K253072",
          "K250207"
        ],
        "severity": 45
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 91 of 100 — 102 companies hold a clearance here and 43 arrived in the last 12 months",
        "recordIds": [
          "HGX:crowding"
        ],
        "severity": 20
      }
    ],
    "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%3AHGX"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHGX"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHGX"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AHGX"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AHGX"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AHGX"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AHGX"
    }
  ],
  "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": "2026-08-11T13:51:45.708Z"
}