{
  "code": "HEB",
  "deviceName": "Tampon, Menstrual, Unscented",
  "deviceClass": "II",
  "regulationNumber": "884.5470",
  "panel": "Obstetrics/Gynecology",
  "definition": "An unscented menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge.",
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 189,
    "last12Months": 5
  },
  "adverseEvents": {
    "total": 1650,
    "last12Months": 300
  },
  "reviewDays": {
    "median": 81,
    "sampleSize": 189
  },
  "recalls": {
    "total": 36,
    "recent": [
      {
        "resNumber": "Z-1182-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "GOLD STAR DISTRIBUTION INC",
        "firmAsPublished": "GOLD STAR DISTRIBUTION INC",
        "reason": "Potential exposure of rodents and rodent activity in the distribution center.",
        "initiated": "2025-12-26"
      },
      {
        "resNumber": "Z-0379-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "DAYE (ANNE'S DAY LTD)",
        "firmAsPublished": "DAYE (ANNE'S DAY LTD)",
        "reason": "Product lacks 510(k) clearance.",
        "initiated": "2025-02-17"
      },
      {
        "resNumber": "Z-0380-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "DAYE (ANNE'S DAY LTD)",
        "firmAsPublished": "DAYE (ANNE'S DAY LTD)",
        "reason": "Product lacks 510(k) clearance.",
        "initiated": "2025-02-17"
      },
      {
        "resNumber": "Z-0381-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "DAYE (ANNE'S DAY LTD)",
        "firmAsPublished": "DAYE (ANNE'S DAY LTD)",
        "reason": "Product lacks 510(k) clearance.",
        "initiated": "2025-02-17"
      },
      {
        "resNumber": "Z-0382-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "DAYE (ANNE'S DAY LTD)",
        "firmAsPublished": "DAYE (ANNE'S DAY LTD)",
        "reason": "Product lacks 510(k) clearance.",
        "initiated": "2025-02-17"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K252005",
      "deviceName": "Livi Device",
      "applicant": "Liviwell, Inc.",
      "company": "Liviwell, Inc.",
      "decisionDate": "2026-03-20",
      "dateReceived": "2025-06-27"
    },
    {
      "kNumber": "K253719",
      "deviceName": "Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons",
      "applicant": "Unibeauty (Hubei) Technology Co., Ltd.",
      "company": "Unibeauty (Hubei) Technology Co., Ltd.",
      "decisionDate": "2025-12-17",
      "dateReceived": "2025-11-24"
    },
    {
      "kNumber": "K252939",
      "deviceName": "COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS",
      "applicant": "Cotton High Tech S.L.",
      "company": "Cotton High Tech S.L.",
      "decisionDate": "2025-10-09",
      "dateReceived": "2025-09-15"
    },
    {
      "kNumber": "K252613",
      "deviceName": "Unscented menstrual three-piece applicator tampon",
      "applicant": "Unibeauty (Hubei) Technology Co., Ltd.",
      "company": "Unibeauty (Hubei) Technology Co., Ltd.",
      "decisionDate": "2025-09-19",
      "dateReceived": "2025-08-19"
    },
    {
      "kNumber": "K251033",
      "deviceName": "Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons",
      "applicant": "Unibeauty (Hubei) Technology Co., Ltd.",
      "company": "Unibeauty (Hubei) Technology Co., Ltd.",
      "decisionDate": "2025-08-13",
      "dateReceived": "2025-04-03"
    },
    {
      "kNumber": "K242105",
      "deviceName": "SABA Tampons",
      "applicant": "Essity Higiene Y Salud Mexico. S.A. DE C.V.",
      "company": "Essity Higiene Y Salud Mexico, S.A. DE C.V.",
      "decisionDate": "2025-04-01",
      "dateReceived": "2024-07-18"
    },
    {
      "kNumber": "K241064",
      "deviceName": "Unscented Tampon",
      "applicant": "Shandong Intco Hygiene Products Co., Ltd.",
      "company": "Shandong Intco Hygiene Products Co., Ltd.",
      "decisionDate": "2025-01-10",
      "dateReceived": "2024-04-18"
    },
    {
      "kNumber": "K240708",
      "deviceName": "Organic Cotton Tampon; Organic Cotton PESCVcord Tampon",
      "applicant": "Suzhou Borage Medical Technology Co., Ltd.",
      "company": "Suzhou Borage Medical Technology Co., Ltd.",
      "decisionDate": "2024-05-10",
      "dateReceived": "2024-03-15"
    },
    {
      "kNumber": "K232060",
      "deviceName": "TOSAMA Reusable Applicator",
      "applicant": "Tosama, D.O.O.",
      "company": "Tosama, D.O.O.",
      "decisionDate": "2024-04-12",
      "dateReceived": "2023-07-11"
    },
    {
      "kNumber": "K232598",
      "deviceName": "Unscented Menstrual Tampon",
      "applicant": "Unibeauty (Hubei) Technology Co., Ltd.",
      "company": "Unibeauty (Hubei) Technology Co., Ltd.",
      "decisionDate": "2023-12-15",
      "dateReceived": "2023-08-28"
    }
  ],
  "topApplicants": [
    {
      "name": "Tambrands, Inc.",
      "count": 34
    },
    {
      "name": "Personal Products Co.",
      "count": 14
    },
    {
      "name": "Kimberly-Clark Corp.",
      "count": 12
    },
    {
      "name": "First Quality Hygienic, Inc.",
      "count": 8
    },
    {
      "name": "Cotton High Tech S.L.",
      "count": 7
    }
  ],
  "topCompanies": [
    {
      "name": "Tambrands, Inc.",
      "count": 34,
      "spellings": 1
    },
    {
      "name": "Kimberly-Clark Corporation",
      "count": 16,
      "spellings": 3
    },
    {
      "name": "Personal Products Company, Div. of Mcneil-Ppc, Inc.",
      "count": 14,
      "spellings": 1
    },
    {
      "name": "First Quality Hygienic, Inc.",
      "count": 8,
      "spellings": 1
    },
    {
      "name": "Cotton High Tech S.L.",
      "count": 7,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Liviwell, Inc.",
      "since": "2026-03-20",
      "kNumber": "K252005"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 52,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 56,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 82,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 55,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 60,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 60,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 69,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 42,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 66,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 35,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 57,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 45,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 52,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 44,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 50,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 50,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 45,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 32,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 47,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 39,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 38,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 43,
        "expectedLow": 20.522008497633436,
        "expectedHigh": 54.2049183736296,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 23,
        "expectedLow": 20.35768571474265,
        "expectedHigh": 48.21263897293487,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 24,
        "expectedLow": 18.555982404445434,
        "expectedHigh": 50.30961171974995,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 35,
        "expectedLow": 14.037797796519573,
        "expectedHigh": 50.87669118292358,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 47,
        "expectedLow": 15.91159480821172,
        "expectedHigh": 46.0907801375953,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 37,
        "expectedLow": 20.193649197930707,
        "expectedHigh": 54.34548071354152,
        "isSufficient": true
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      {
        "month": "2025-07-01",
        "observed": 35,
        "expectedLow": 35.556565994279914,
        "expectedHigh": 81.01623479798539,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 40,
        "expectedLow": 20.065214936483525,
        "expectedHigh": 57.349194642056965,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 45,
        "expectedLow": 21.729852029659646,
        "expectedHigh": 60.20412219161663,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 43,
        "expectedLow": 23.27381996019505,
        "expectedHigh": 60.892877209508455,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 38,
        "expectedLow": 21.5685569333025,
        "expectedHigh": 54.6447341162045,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 31,
        "expectedLow": 23.863641415212253,
        "expectedHigh": 60.45061234521464,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 30,
        "expectedLow": 22.61838473238334,
        "expectedHigh": 67.29085997194032,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 37,
        "expectedLow": 14.657445122300222,
        "expectedHigh": 53.26380311433495,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 47,
        "expectedLow": 17.515446231496103,
        "expectedHigh": 58.881997642539794,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "HEB (Tampon, Menstrual, Unscented) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-1182-2026). 1 first-time filer in the last 12 months, Liviwell, Inc (K252005). The code is crowded, scoring 66 of 100 — 58 companies hold a clearance here and 5 arrived in the last 12 months (HEB:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-1182-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Liviwell, Inc.",
        "recordIds": [
          "K252005"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 66 of 100 — 58 companies hold a clearance here and 5 arrived in the last 12 months",
        "recordIds": [
          "HEB: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%3AHEB"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHEB"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHEB"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AHEB"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AHEB"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AHEB"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AHEB"
    }
  ],
  "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": "2026-08-11T13:51:45.707Z"
}