{
  "code": "KNT",
  "deviceName": "Tubes, Gastrointestinal (And Accessories)",
  "deviceClass": "II",
  "regulationNumber": "876.5980",
  "panel": "Gastroenterology, Urology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 650,
    "last12Months": 1
  },
  "adverseEvents": {
    "total": 4735,
    "last12Months": 1011
  },
  "reviewDays": {
    "median": 94,
    "sampleSize": 650
  },
  "recalls": {
    "total": 268,
    "recent": [
      {
        "resNumber": "Z-2333-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Avanos Medical, Inc.",
        "firmAsPublished": "Avanos Medical, Inc.",
        "reason": "Lidocaine hydrochloride injection, the subject of a supplier recall for  quality issues, were included into sterile kits and sets.",
        "initiated": "2026-04-30"
      },
      {
        "resNumber": "Z-2334-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Avanos Medical, Inc.",
        "firmAsPublished": "Avanos Medical, Inc.",
        "reason": "Lidocaine hydrochloride injection, the subject of a supplier recall for  quality issues, were included into sterile kits and sets.",
        "initiated": "2026-04-30"
      },
      {
        "resNumber": "Z-2335-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Avanos Medical, Inc.",
        "firmAsPublished": "Avanos Medical, Inc.",
        "reason": "Lidocaine hydrochloride injection, the subject of a supplier recall for  quality issues, were included into sterile kits and sets.",
        "initiated": "2026-04-30"
      },
      {
        "resNumber": "Z-2336-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Avanos Medical, Inc.",
        "firmAsPublished": "Avanos Medical, Inc.",
        "reason": "Lidocaine hydrochloride injection, the subject of a supplier recall for  quality issues, were included into sterile kits and sets.",
        "initiated": "2026-04-30"
      },
      {
        "resNumber": "Z-2337-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Avanos Medical, Inc.",
        "firmAsPublished": "Avanos Medical, Inc.",
        "reason": "Lidocaine hydrochloride injection, the subject of a supplier recall for  quality issues, were included into sterile kits and sets.",
        "initiated": "2026-04-30"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253514",
      "deviceName": "Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)",
      "applicant": "C.R. Bard, Inc.",
      "company": "C.R. Bard, Inc.",
      "decisionDate": "2026-07-10",
      "dateReceived": "2025-11-06"
    },
    {
      "kNumber": "K250389",
      "deviceName": "XNY Disposable Gastric Calibration Tube",
      "applicant": "Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd",
      "company": "Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd",
      "decisionDate": "2025-04-10",
      "dateReceived": "2025-02-11"
    },
    {
      "kNumber": "K243228",
      "deviceName": "Flexi-Seal AIR (with ENFit Connector)",
      "applicant": "Convatec",
      "company": "Convatec Inc.",
      "decisionDate": "2025-03-28",
      "dateReceived": "2024-10-08"
    },
    {
      "kNumber": "K242336",
      "deviceName": "hygh-tec Drainage II",
      "applicant": "Amb Medtec",
      "company": "Amb Medtec",
      "decisionDate": "2025-01-17",
      "dateReceived": "2024-08-07"
    },
    {
      "kNumber": "K242901",
      "deviceName": "ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)",
      "applicant": "Tools For Surgery, LLC",
      "company": "Tools For Surgery, LLC",
      "decisionDate": "2025-01-10",
      "dateReceived": "2024-09-23"
    },
    {
      "kNumber": "K241169",
      "deviceName": "Entarik NI Feeding Tube System",
      "applicant": "Gravitas Medical, Inc.",
      "company": "Gravitas Medical, Inc.",
      "decisionDate": "2024-11-22",
      "dateReceived": "2024-04-26"
    },
    {
      "kNumber": "K241185",
      "deviceName": "CORGRIP* SR NG/NI Tube Retention System",
      "applicant": "Avanos Medical, Inc.",
      "company": "Avanos Medical, Inc.",
      "decisionDate": "2024-10-25",
      "dateReceived": "2024-04-29"
    },
    {
      "kNumber": "K240965",
      "deviceName": "CORTRAK* 2 Enteral Access System (20-0950)",
      "applicant": "Avanos Medical, Inc.",
      "company": "Avanos Medical, Inc.",
      "decisionDate": "2024-06-06",
      "dateReceived": "2024-04-09"
    },
    {
      "kNumber": "K233591",
      "deviceName": "Stylus",
      "applicant": "Degania Silicone , Ltd.",
      "company": "Degania Silicone, Ltd.",
      "decisionDate": "2024-05-31",
      "dateReceived": "2023-11-08"
    },
    {
      "kNumber": "K241039",
      "deviceName": "ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020)",
      "applicant": "Reshape Lifesciences",
      "company": "Reshape Lifesciences",
      "decisionDate": "2024-05-16",
      "dateReceived": "2024-04-16"
    }
  ],
  "topApplicants": [
    {
      "name": "Biosearch Medical Products, Inc.",
      "count": 35
    },
    {
      "name": "Abbott Laboratories",
      "count": 23
    },
    {
      "name": "Medical Innovations Corp.",
      "count": 18
    },
    {
      "name": "Applied Medical Technology, Inc.",
      "count": 16
    },
    {
      "name": "C.R. Bard, Inc.",
      "count": 15
    }
  ],
  "topCompanies": [
    {
      "name": "Biosearch Medical Products, Inc.",
      "count": 35,
      "spellings": 1
    },
    {
      "name": "Abbott Laboratories, Inc.",
      "count": 23,
      "spellings": 1
    },
    {
      "name": "Medical Innovations Corp.",
      "count": 18,
      "spellings": 1
    },
    {
      "name": "Applied Medical Technology Inc",
      "count": 16,
      "spellings": 1
    },
    {
      "name": "C.R. Bard, Inc.",
      "count": 15,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 156,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 170,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 198,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 173,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 138,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 154,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 160,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 160,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 96,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 123,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 164,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 120,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 112,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 132,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 101,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 106,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 107,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 98,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 120,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 125,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 115,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 111,
        "expectedLow": 66.82436811042443,
        "expectedHigh": 143.59496044360353,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 89,
        "expectedLow": 60.427466570931735,
        "expectedHigh": 126.90068770665707,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 114,
        "expectedLow": 81.5915451074108,
        "expectedHigh": 123.81000738981179,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 119,
        "expectedLow": 88.76808777013804,
        "expectedHigh": 130.32641610632615,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 147,
        "expectedLow": 85.4352874767227,
        "expectedHigh": 125.61213788217272,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 126,
        "expectedLow": 88.31978435933415,
        "expectedHigh": 155.80028301957822,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 124,
        "expectedLow": 137.8480053116563,
        "expectedHigh": 249.14516014233064,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 106,
        "expectedLow": 85.10325582459292,
        "expectedHigh": 175.91886475688193,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 115,
        "expectedLow": 81.0161255214481,
        "expectedHigh": 178.05027288900217,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 111,
        "expectedLow": 76.91273472313324,
        "expectedHigh": 172.21819334623706,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 142,
        "expectedLow": 64.35177043410816,
        "expectedHigh": 153.20344851986752,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 135,
        "expectedLow": 80.21019627631541,
        "expectedHigh": 182.53224272120121,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 106,
        "expectedLow": 94.31865406268308,
        "expectedHigh": 211.6666718803277,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 158,
        "expectedLow": 62.17291961284188,
        "expectedHigh": 172.5263124027689,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 167,
        "expectedLow": 79.16111404989171,
        "expectedHigh": 205.41187065129418,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "KNT (Tubes, Gastrointestinal (And Accessories)) has two findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2333-2026, Z-2334-2026, Z-2335-2026, Z-2336-2026, Z-2337-2026). The code is crowded, scoring 65 of 100 — 260 companies hold a clearance here and 1 arrived in the last 12 months (KNT:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2333-2026",
          "Z-2334-2026",
          "Z-2335-2026",
          "Z-2336-2026",
          "Z-2337-2026"
        ],
        "severity": 75
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 65 of 100 — 260 companies hold a clearance here and 1 arrived in the last 12 months",
        "recordIds": [
          "KNT: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%3AKNT"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKNT"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKNT"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AKNT"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AKNT"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AKNT"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AKNT"
    }
  ],
  "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": "2026-08-11T13:51:45.733Z"
}