{
  "code": "KNS",
  "deviceName": "Unit, Electrosurgical, Endoscopic (With Or Without Accessories)",
  "deviceClass": "II",
  "regulationNumber": "876.4300",
  "panel": "Gastroenterology, Urology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 188,
    "last12Months": 6
  },
  "adverseEvents": {
    "total": 4238,
    "last12Months": 1228
  },
  "reviewDays": {
    "median": 78,
    "sampleSize": 188
  },
  "recalls": {
    "total": 121,
    "recent": [
      {
        "resNumber": "Z-1268-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Olympus Corporation of the Americas",
        "firmAsPublished": "Olympus Corporation of the Americas",
        "reason": "Devices which did not undergo thermoforming could deform and lose performance.",
        "initiated": "2026-01-07"
      },
      {
        "resNumber": "Z-1269-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Olympus Corporation of the Americas",
        "firmAsPublished": "Olympus Corporation of the Americas",
        "reason": "Devices which did not undergo thermoforming could deform and lose performance.",
        "initiated": "2026-01-07"
      },
      {
        "resNumber": "Z-1270-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Olympus Corporation of the Americas",
        "firmAsPublished": "Olympus Corporation of the Americas",
        "reason": "Devices which did not undergo thermoforming could deform and lose performance.",
        "initiated": "2026-01-07"
      },
      {
        "resNumber": "Z-1271-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Olympus Corporation of the Americas",
        "firmAsPublished": "Olympus Corporation of the Americas",
        "reason": "Devices which did not undergo thermoforming could deform and lose performance.",
        "initiated": "2026-01-07"
      },
      {
        "resNumber": "Z-1272-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Olympus Corporation of the Americas",
        "firmAsPublished": "Olympus Corporation of the Americas",
        "reason": "Devices which did not undergo thermoforming could deform and lose performance.",
        "initiated": "2026-01-07"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K260962",
      "deviceName": "Sphincterotome",
      "applicant": "Taewoong Medical Co., Ltd.",
      "company": "Taewoong Medical Co., Ltd.",
      "decisionDate": "2026-05-21",
      "dateReceived": "2026-03-23"
    },
    {
      "kNumber": "K252388",
      "deviceName": "Vanquish Water Vapor Ablation Device",
      "applicant": "Francis Medical, Inc.",
      "company": "Francis Medical, Inc.",
      "decisionDate": "2025-11-26",
      "dateReceived": "2025-07-31"
    },
    {
      "kNumber": "K252889",
      "deviceName": "Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)",
      "applicant": "Olympus Medical Systems Corporation",
      "company": "Olympus Medical Systems Corporation",
      "decisionDate": "2025-11-25",
      "dateReceived": "2025-09-10"
    },
    {
      "kNumber": "K250945",
      "deviceName": "Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)",
      "applicant": "Olympus Medical Systems Corp.",
      "company": "Olympus Medical Systems Corporation",
      "decisionDate": "2025-10-17",
      "dateReceived": "2025-03-28"
    },
    {
      "kNumber": "K250351",
      "deviceName": "Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)",
      "applicant": "Olympus Medical Systems Corporation",
      "company": "Olympus Medical Systems Corporation",
      "decisionDate": "2025-10-10",
      "dateReceived": "2025-02-07"
    },
    {
      "kNumber": "K251104",
      "deviceName": "SureTome™ SW Sphincterotome with DomeTip",
      "applicant": "Wilson-Cook Medical",
      "company": "Wilson-Cook Medical Inc.",
      "decisionDate": "2025-09-29",
      "dateReceived": "2025-04-11"
    },
    {
      "kNumber": "K251226",
      "deviceName": "Aqua Medical RF Vapor Ablation System",
      "applicant": "Aqua Medical, Inc.",
      "company": "Aqua Medical, Inc.",
      "decisionDate": "2025-08-08",
      "dateReceived": "2025-04-21"
    },
    {
      "kNumber": "K250584",
      "deviceName": "Rezum System",
      "applicant": "Boston Scientific Corporation",
      "company": "Boston Scientific Corporation",
      "decisionDate": "2025-06-11",
      "dateReceived": "2025-02-27"
    },
    {
      "kNumber": "K242774",
      "deviceName": "SpydrBlade Flex Instrument (PRD-RG1-001)",
      "applicant": "Creo Medical, Ltd.",
      "company": "Creo Medical, Ltd.",
      "decisionDate": "2025-06-06",
      "dateReceived": "2024-09-13"
    },
    {
      "kNumber": "K241855",
      "deviceName": "SB Knife Jr2 (MD-47702 and MD-47702L)",
      "applicant": "Sb-Kawasumi Laboratories, Inc.",
      "company": "Sb-Kawasumi Laboratories, Inc.",
      "decisionDate": "2025-03-26",
      "dateReceived": "2024-06-27"
    }
  ],
  "topApplicants": [
    {
      "name": "Wilson-Cook Medical, Inc.",
      "count": 11
    },
    {
      "name": "Boston Scientific Corp",
      "count": 9
    },
    {
      "name": "Boston Scientific Corporation",
      "count": 7
    },
    {
      "name": "Olympus Medical Systems Corp.",
      "count": 7
    },
    {
      "name": "Aqua Medical, Inc.",
      "count": 5
    }
  ],
  "topCompanies": [
    {
      "name": "Boston Scientific Corporation",
      "count": 17,
      "spellings": 3
    },
    {
      "name": "Wilson-Cook Medical Inc.",
      "count": 12,
      "spellings": 2
    },
    {
      "name": "Olympus Medical Systems Corporation",
      "count": 10,
      "spellings": 2
    },
    {
      "name": "Aqua Medical, Inc.",
      "count": 5,
      "spellings": 1
    },
    {
      "name": "Creo Medical, Ltd.",
      "count": 5,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Francis Medical, Inc.",
      "since": "2025-11-26",
      "kNumber": "K252388"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 60,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 83,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 78,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 61,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 78,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 79,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 76,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 79,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 84,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 137,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 183,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 125,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 111,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 144,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 93,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 110,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 153,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 105,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 105,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 122,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 146,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 54,
        "expectedLow": 65.05071156911534,
        "expectedHigh": 165.50211172307326,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 80,
        "expectedLow": 30.50791532838817,
        "expectedHigh": 139.4332893340776,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 90,
        "expectedLow": 46.342690128250645,
        "expectedHigh": 139.02877067078205,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 105,
        "expectedLow": 47.968376440516536,
        "expectedHigh": 141.58217454654792,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 122,
        "expectedLow": 48.499139677744964,
        "expectedHigh": 135.5952441721214,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 147,
        "expectedLow": 60.438858233972105,
        "expectedHigh": 148.03777759121417,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 139,
        "expectedLow": 103.66470589945365,
        "expectedHigh": 264.418061812424,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 147,
        "expectedLow": 68.08628437094389,
        "expectedHigh": 190.93499318533756,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 177,
        "expectedLow": 78.5228742092158,
        "expectedHigh": 203.79333180904646,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 155,
        "expectedLow": 83.3899360607572,
        "expectedHigh": 218.21339643553134,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 125,
        "expectedLow": 77.24923561149555,
        "expectedHigh": 197.50777170732076,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 148,
        "expectedLow": 81.78035005594569,
        "expectedHigh": 215.05627164963113,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 115,
        "expectedLow": 93.8402356413335,
        "expectedHigh": 245.39388207982748,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 94,
        "expectedLow": 77.23681776472245,
        "expectedHigh": 183.2506453937737,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 297,
        "expectedLow": 69.09415502253442,
        "expectedHigh": 192.65656130072122,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1268-2026, Z-1269-2026, Z-1270-2026, Z-1271-2026, Z-1272-2026). Adverse events reported in 2026-03 ran high — 297 reports against an expected 69 to 193 (KNS:MAUDE:2026-03). 1 first-time filer in the last 12 months, Francis Medical, Inc (K252388). The code is crowded, scoring 72 of 100 — 87 companies hold a clearance here and 6 arrived in the last 12 months (KNS:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-1268-2026",
          "Z-1269-2026",
          "Z-1270-2026",
          "Z-1271-2026",
          "Z-1272-2026"
        ],
        "severity": 75
      },
      {
        "kind": "spike",
        "detail": "adverse events reported in 2026-03 ran high — 297 reports against an expected 69 to 193",
        "recordIds": [
          "KNS:MAUDE:2026-03"
        ],
        "severity": 69
      },
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Francis Medical, Inc.",
        "recordIds": [
          "K252388"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 72 of 100 — 87 companies hold a clearance here and 6 arrived in the last 12 months",
        "recordIds": [
          "KNS: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%3AKNS"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKNS"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKNS"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AKNS"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AKNS"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AKNS"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AKNS"
    }
  ],
  "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": "2026-08-11T13:51:45.732Z"
}