{
  "code": "JXG",
  "deviceName": "Shunt, Central Nervous System And Components",
  "deviceClass": "II",
  "regulationNumber": "882.5550",
  "panel": "Neurology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 259,
    "last12Months": 4
  },
  "adverseEvents": {
    "total": 3603,
    "last12Months": 783
  },
  "reviewDays": {
    "median": 89,
    "sampleSize": 259
  },
  "recalls": {
    "total": 108,
    "recent": [
      {
        "resNumber": "Z-2173-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Integra LifeSciences Corp. (NeuroSciences)",
        "firmAsPublished": "Integra LifeSciences Corp. (NeuroSciences)",
        "reason": "Out-of-specification endotoxin result that did not meet the acceptance criteria.",
        "initiated": "2026-04-10"
      },
      {
        "resNumber": "Z-0977-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Integra LifeSciences Corporation",
        "firmAsPublished": "Integra LifeSciences Corp.",
        "reason": "Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.",
        "initiated": "2024-12-16"
      },
      {
        "resNumber": "Z-0978-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Integra LifeSciences Corporation",
        "firmAsPublished": "Integra LifeSciences Corp.",
        "reason": "Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.",
        "initiated": "2024-12-16"
      },
      {
        "resNumber": "Z-0979-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Integra LifeSciences Corporation",
        "firmAsPublished": "Integra LifeSciences Corp.",
        "reason": "Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.",
        "initiated": "2024-12-16"
      },
      {
        "resNumber": "Z-2136-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Integra LifeSciences Corporation",
        "firmAsPublished": "Integra LifeSciences Corp.",
        "reason": "Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.",
        "initiated": "2024-05-07"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261004",
      "deviceName": "Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)",
      "applicant": "Integra Lifesciences Production Corporation",
      "company": "Integra Lifesciences Production Corporation",
      "decisionDate": "2026-06-23",
      "dateReceived": "2026-03-26"
    },
    {
      "kNumber": "K251598",
      "deviceName": "Intellidrop",
      "applicant": "Brainspace, Inc.",
      "company": "Brainspace, Inc.",
      "decisionDate": "2025-12-10",
      "dateReceived": "2025-05-27"
    },
    {
      "kNumber": "K250636",
      "deviceName": "Sophy Mini Monopressure Valve (SM1)",
      "applicant": "Sophysa",
      "company": "Sophysa",
      "decisionDate": "2025-11-28",
      "dateReceived": "2025-03-03"
    },
    {
      "kNumber": "K252514",
      "deviceName": "EVAC-MRI",
      "applicant": "Phasor Health, LLC",
      "company": "Phasor Health, LLC",
      "decisionDate": "2025-11-05",
      "dateReceived": "2025-08-11"
    },
    {
      "kNumber": "K243531",
      "deviceName": "Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology",
      "applicant": "Integra Lifesciences Production Corporation",
      "company": "Integra Lifesciences Production Corporation",
      "decisionDate": "2025-08-08",
      "dateReceived": "2024-11-14"
    },
    {
      "kNumber": "K243552",
      "deviceName": "Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)",
      "applicant": "Integra Lifesciences Production Corporation",
      "company": "Integra Lifesciences Production Corporation",
      "decisionDate": "2025-08-06",
      "dateReceived": "2024-11-15"
    },
    {
      "kNumber": "K242974",
      "deviceName": "External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters",
      "applicant": "Sophysa",
      "company": "Sophysa",
      "decisionDate": "2025-06-20",
      "dateReceived": "2024-09-26"
    },
    {
      "kNumber": "K243205",
      "deviceName": "EVAC",
      "applicant": "Phasor Health, LLC",
      "company": "Phasor Health, LLC",
      "decisionDate": "2025-06-03",
      "dateReceived": "2024-10-01"
    },
    {
      "kNumber": "K243676",
      "deviceName": "Duet External Drainage and Monitoring System (EDMS)",
      "applicant": "Medtronic Neurosurgery",
      "company": "Medtronic Neurosurgery",
      "decisionDate": "2025-03-10",
      "dateReceived": "2024-11-27"
    },
    {
      "kNumber": "K242003",
      "deviceName": "XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set",
      "applicant": "Aesculap, Inc.",
      "company": "Aesculap, Inc.",
      "decisionDate": "2024-12-16",
      "dateReceived": "2024-07-09"
    }
  ],
  "topApplicants": [
    {
      "name": "Codman & Shurtleff, Inc.",
      "count": 23
    },
    {
      "name": "Holter-Hausner Intl.",
      "count": 21
    },
    {
      "name": "Cordis Corp.",
      "count": 18
    },
    {
      "name": "Medtronic Neurosurgery",
      "count": 18
    },
    {
      "name": "Pudenz-Schulte Medical Research Corp.",
      "count": 18
    }
  ],
  "topCompanies": [
    {
      "name": "Codman & Shurtleff, Inc.",
      "count": 23,
      "spellings": 1
    },
    {
      "name": "Holter-Hausner Intl.",
      "count": 21,
      "spellings": 1
    },
    {
      "name": "Cordis Corporation",
      "count": 18,
      "spellings": 1
    },
    {
      "name": "Medtronic Neurosurgery",
      "count": 18,
      "spellings": 1
    },
    {
      "name": "Pudenz-Schulte Medical Research Corp.",
      "count": 18,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Brainspace, Inc.",
      "since": "2025-12-10",
      "kNumber": "K251598"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 88,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 102,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 79,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 85,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 116,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 101,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 94,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 119,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 96,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 80,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 103,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 81,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 92,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 108,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 82,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 99,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 107,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 120,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 112,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 120,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 110,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 74,
        "expectedLow": 78.99126886438567,
        "expectedHigh": 121.51224343782171,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 73,
        "expectedLow": 61.28738540834424,
        "expectedHigh": 100.21163223870299,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 80,
        "expectedLow": 65.31224443535852,
        "expectedHigh": 109.67221918844834,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 98,
        "expectedLow": 65.33974513704189,
        "expectedHigh": 111.19744224649612,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 105,
        "expectedLow": 64.00920457120422,
        "expectedHigh": 107.22735253035435,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 124,
        "expectedLow": 70.39338322590918,
        "expectedHigh": 118.7792233943923,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 109,
        "expectedLow": 116.07923030839112,
        "expectedHigh": 209.14022276664778,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 111,
        "expectedLow": 71.78786531436384,
        "expectedHigh": 149.94996185360952,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 79,
        "expectedLow": 75.87350060026631,
        "expectedHigh": 158.10604430021738,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 116,
        "expectedLow": 59.92393711337885,
        "expectedHigh": 149.38019194715685,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 107,
        "expectedLow": 57.33395455462131,
        "expectedHigh": 137.86916731543798,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 107,
        "expectedLow": 68.4849358417333,
        "expectedHigh": 153.65277017313605,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 92,
        "expectedLow": 77.4700767290712,
        "expectedHigh": 175.07361824111553,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 87,
        "expectedLow": 54.932323214515975,
        "expectedHigh": 141.62754448507192,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 108,
        "expectedLow": 55.038525167173276,
        "expectedHigh": 152.96883432687088,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "JXG (Shunt, Central Nervous System And Components) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-2173-2026). 1 first-time filer in the last 12 months, Brainspace, Inc (K251598). The code is crowded, scoring 64 of 100 — 55 companies hold a clearance here and 4 arrived in the last 12 months (JXG:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2173-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Brainspace, Inc.",
        "recordIds": [
          "K251598"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 64 of 100 — 55 companies hold a clearance here and 4 arrived in the last 12 months",
        "recordIds": [
          "JXG: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%3AJXG"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJXG"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJXG"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJXG"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJXG"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJXG"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJXG"
    }
  ],
  "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": "2026-08-11T13:51:45.729Z"
}