{
  "code": "HIS",
  "deviceName": "Condom",
  "deviceClass": "II",
  "regulationNumber": "884.5300",
  "panel": "Obstetrics/Gynecology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 401,
    "last12Months": 2
  },
  "adverseEvents": {
    "total": 38,
    "last12Months": 14
  },
  "reviewDays": {
    "median": 115,
    "sampleSize": 401
  },
  "recalls": {
    "total": 7,
    "recent": [
      {
        "resNumber": "Z-1181-2026",
        "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-1546-2022",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Family Dollar Stores, Llc.",
        "firmAsPublished": "Family Dollar Stores, Llc.",
        "reason": "Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.",
        "initiated": "2022-06-23"
      },
      {
        "resNumber": "Z-1249-2017",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Reckitt Benckiser LLC",
        "firmAsPublished": "Reckitt Benckiser LLC",
        "reason": "Reckitt Benckiser LLC is recalling Durex Condoms Pleasure Packs due to missing information on the package labeling associated with the active ingredient Benzocaine.",
        "initiated": "2016-11-22"
      },
      {
        "resNumber": "Z-0838-2013",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Ansell Healthcare Products LLC",
        "firmAsPublished": "Ansell Healthcare Products LLC",
        "reason": "Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product.  The condom has met or exceeded test and quality standards required by the Food and Drug Administration.  However, we are experiencing a number of complaints concerning the difficulty in unrolling and subsequent breakage, and so we are asking to have all products returned.",
        "initiated": "2013-01-14"
      },
      {
        "resNumber": "Z-0717-2013",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Ansell Healthcare Products LLC",
        "firmAsPublished": "Ansell Healthcare Products LLC",
        "reason": "One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn.",
        "initiated": "2012-11-05"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K252622",
      "deviceName": "Male Latex Condom HA",
      "applicant": "Okamoto USA, Inc.",
      "company": "Okamoto USA, Inc.",
      "decisionDate": "2026-05-04",
      "dateReceived": "2025-08-19"
    },
    {
      "kNumber": "K252521",
      "deviceName": "LifeStyles® HydraFeel Natural Rubber Latex Condom",
      "applicant": "Suretex Limited",
      "company": "Suretex Limited",
      "decisionDate": "2025-11-18",
      "dateReceived": "2025-08-11"
    },
    {
      "kNumber": "K250034",
      "deviceName": "Natural rubber latex male condom",
      "applicant": "Shaoguan Regenex Pharmaceuticals Co., Ltd.",
      "company": "Shaoguan Regenex Pharmaceuticals Co., Ltd.",
      "decisionDate": "2025-07-11",
      "dateReceived": "2025-01-07"
    },
    {
      "kNumber": "K243421",
      "deviceName": "Lelo Hex Lubricated Natural Rubber Latex Condom",
      "applicant": "Lelo, Inc.",
      "company": "Lelo, Inc.",
      "decisionDate": "2025-03-07",
      "dateReceived": "2024-11-04"
    },
    {
      "kNumber": "K243640",
      "deviceName": "Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)",
      "applicant": "Church & Dwight Co., Inc.",
      "company": "Church & Dwight Inc",
      "decisionDate": "2025-02-21",
      "dateReceived": "2024-11-25"
    },
    {
      "kNumber": "K243584",
      "deviceName": "0.04 ZERO ZERO FOUR Male Latex Condom",
      "applicant": "Okamoto USA, Inc.",
      "company": "Okamoto USA, Inc.",
      "decisionDate": "2025-02-18",
      "dateReceived": "2024-11-20"
    },
    {
      "kNumber": "K232279",
      "deviceName": "LifeStyles NRL Textured Condom",
      "applicant": "Suretex Limited",
      "company": "Suretex Limited",
      "decisionDate": "2023-10-05",
      "dateReceived": "2023-07-31"
    },
    {
      "kNumber": "K230049",
      "deviceName": "SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT",
      "applicant": "Ttk Healthcare Limited",
      "company": "Ttk Healthcare Limited",
      "decisionDate": "2023-09-07",
      "dateReceived": "2023-01-06"
    },
    {
      "kNumber": "K222611",
      "deviceName": "Male Latex Condoms",
      "applicant": "Suzhou Colour-Way New Material Co., Ltd.",
      "company": "Suzhou Colour-way New Material Co., Ltd.",
      "decisionDate": "2022-11-28",
      "dateReceived": "2022-08-30"
    },
    {
      "kNumber": "K220489",
      "deviceName": "Durex Patronus CloseFit, Durex Patronus Regular",
      "applicant": "Rb Health (Us), LLC",
      "company": "Rb Health (Us), LLC",
      "decisionDate": "2022-11-07",
      "dateReceived": "2022-02-22"
    }
  ],
  "topApplicants": [
    {
      "name": "Carter Products",
      "count": 15
    },
    {
      "name": "Okamoto USA, Inc.",
      "count": 14
    },
    {
      "name": "Mayer Laboratories",
      "count": 13
    },
    {
      "name": "Ansell, Inc.",
      "count": 12
    },
    {
      "name": "Church & Dwight Co., Inc.",
      "count": 12
    }
  ],
  "topCompanies": [
    {
      "name": "Carter Products",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "Mayer Laboratories, Inc.",
      "count": 14,
      "spellings": 2
    },
    {
      "name": "Okamoto USA, Inc.",
      "count": 14,
      "spellings": 1
    },
    {
      "name": "Ansell, Inc.",
      "count": 12,
      "spellings": 1
    },
    {
      "name": "Church & Dwight Inc",
      "count": 12,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-05-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "HIS (Condom) has two findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-1181-2026). The code is crowded, scoring 66 of 100 — 172 companies hold a clearance here and 2 arrived in the last 12 months (HIS:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-1181-2026"
        ],
        "severity": 75
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 66 of 100 — 172 companies hold a clearance here and 2 arrived in the last 12 months",
        "recordIds": [
          "HIS: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%3AHIS"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHIS"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AHIS"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AHIS"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AHIS"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AHIS"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AHIS"
    }
  ],
  "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"
}