{
  "code": "KDI",
  "deviceName": "Dialyzer, High Permeability With Or Without Sealed Dialysate System",
  "deviceClass": "II",
  "regulationNumber": "876.5860",
  "panel": "Gastroenterology, Urology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 345,
    "last12Months": 7
  },
  "adverseEvents": {
    "total": 7881,
    "last12Months": 1857
  },
  "reviewDays": {
    "median": 125,
    "sampleSize": 345
  },
  "recalls": {
    "total": 216,
    "recent": [
      {
        "resNumber": "Z-2702-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Fresenius Medical Care Holdings, Inc. dba Renal Solutions",
        "firmAsPublished": "Fresenius Medical Care Holdings, Inc.",
        "reason": "Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.",
        "initiated": "2026-05-11"
      },
      {
        "resNumber": "Z-1224-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Vantive US Healthcare LLC",
        "firmAsPublished": "VANTIVE US HEALTHCARE LLC",
        "reason": "There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.",
        "initiated": "2026-01-06"
      },
      {
        "resNumber": "Z-1225-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Vantive US Healthcare LLC",
        "firmAsPublished": "VANTIVE US HEALTHCARE LLC",
        "reason": "There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.",
        "initiated": "2026-01-06"
      },
      {
        "resNumber": "Z-1226-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Vantive US Healthcare LLC",
        "firmAsPublished": "VANTIVE US HEALTHCARE LLC",
        "reason": "There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.",
        "initiated": "2026-01-06"
      },
      {
        "resNumber": "Z-1227-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Vantive US Healthcare LLC",
        "firmAsPublished": "VANTIVE US HEALTHCARE LLC",
        "reason": "There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.",
        "initiated": "2026-01-06"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261267",
      "deviceName": "Careflux H60;Careflux H70;Careflux V500",
      "applicant": "Fresenius Medical Care Renal Therapies Group, LLC",
      "company": "Fresenius Medical Care Renal Therapies Group, LLC",
      "decisionDate": "2026-07-24",
      "dateReceived": "2026-04-16"
    },
    {
      "kNumber": "K252377",
      "deviceName": "NxStage System One with NxView",
      "applicant": "Fresenius Medical Care Renal Therapies Group, LLC",
      "company": "Fresenius Medical Care Renal Therapies Group, LLC",
      "decisionDate": "2026-05-15",
      "dateReceived": "2025-07-30"
    },
    {
      "kNumber": "K260533",
      "deviceName": "ELISIO™-H",
      "applicant": "Nipro Medical Corporation",
      "company": "Nipro Medical Corporation",
      "decisionDate": "2026-03-19",
      "dateReceived": "2026-02-17"
    },
    {
      "kNumber": "K252459",
      "deviceName": "multiFlux 130 (F00013123); multiFlux 160 (F00013124)",
      "applicant": "Fresenius Medical Care Renal Therapies Group, LLC",
      "company": "Fresenius Medical Care Renal Therapies Group, LLC",
      "decisionDate": "2026-02-10",
      "dateReceived": "2025-08-05"
    },
    {
      "kNumber": "K253412",
      "deviceName": "Tablo Hemodialysis System (PN-0008000, PN-0006000U)",
      "applicant": "Outset Medical, Inc.",
      "company": "Outset Medical, Inc.",
      "decisionDate": "2026-01-26",
      "dateReceived": "2025-09-30"
    },
    {
      "kNumber": "K253518",
      "deviceName": "FX CorAL 40; FX CorAL 50",
      "applicant": "Fresenius Medical Care Renal Therapies Group, LLC",
      "company": "Fresenius Medical Care Renal Therapies Group, LLC",
      "decisionDate": "2025-12-18",
      "dateReceived": "2025-11-12"
    },
    {
      "kNumber": "K243920",
      "deviceName": "Purema H Hemoconcentrator - Pediatric",
      "applicant": "Medica USA, Inc.",
      "company": "Medica USA, Inc.",
      "decisionDate": "2025-09-19",
      "dateReceived": "2024-12-20"
    },
    {
      "kNumber": "K250508",
      "deviceName": "AK 98 Dialysis Machine (955607)",
      "applicant": "Vantive US Healthcare, LLC",
      "company": "Vantive US Healthcare LLC",
      "decisionDate": "2025-08-01",
      "dateReceived": "2025-02-21"
    },
    {
      "kNumber": "K243237",
      "deviceName": "2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)",
      "applicant": "Fresenius Medical Care Renal Therapies Group, LLC",
      "company": "Fresenius Medical Care Renal Therapies Group, LLC",
      "decisionDate": "2025-06-13",
      "dateReceived": "2024-10-10"
    },
    {
      "kNumber": "K243505",
      "deviceName": "5008X Hemodialysis System",
      "applicant": "Fresenius Medical Care Renal Therapies Group, LLC",
      "company": "Fresenius Medical Care Renal Therapies Group, LLC",
      "decisionDate": "2025-05-30",
      "dateReceived": "2024-11-12"
    }
  ],
  "topApplicants": [
    {
      "name": "Nxstage Medical, Inc.",
      "count": 26
    },
    {
      "name": "Hospal Medical Corp.",
      "count": 20
    },
    {
      "name": "Fresenius Medical Care Renal Therapies Group, LLC",
      "count": 19
    },
    {
      "name": "Althin Medical AB an Affiliate of Baxter Intl",
      "count": 18
    },
    {
      "name": "Baxter Healthcare Corp",
      "count": 18
    }
  ],
  "topCompanies": [
    {
      "name": "Baxter Healthcare Corporation",
      "count": 26,
      "spellings": 2
    },
    {
      "name": "NxStage Medical, Inc.",
      "count": 26,
      "spellings": 1
    },
    {
      "name": "Hospal Medical Corp.",
      "count": 20,
      "spellings": 1
    },
    {
      "name": "Fresenius Medical Care Renal Therapies Group, LLC",
      "count": 19,
      "spellings": 1
    },
    {
      "name": "Althin Medical AB an Affiliate of Baxter Intl",
      "count": 18,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Medica USA, Inc.",
      "since": "2025-09-19",
      "kNumber": "K243920"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 191,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 203,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 256,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 193,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 242,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 222,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 176,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 284,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 194,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 214,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 201,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 233,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 248,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 182,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 192,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 192,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 225,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 201,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 169,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 201,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 183,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 241,
        "expectedLow": 115.20571541398357,
        "expectedHigh": 236.78221749604018,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 170,
        "expectedLow": 112.24002769093032,
        "expectedHigh": 228.094394195704,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 213,
        "expectedLow": 126.0630636151648,
        "expectedHigh": 255.67317685863395,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 200,
        "expectedLow": 140.61693906796214,
        "expectedHigh": 268.1226453511544,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 186,
        "expectedLow": 140.70613689275856,
        "expectedHigh": 238.0190896236166,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 215,
        "expectedLow": 146.5391108915519,
        "expectedHigh": 244.85013903100796,
        "isSufficient": true
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      {
        "month": "2025-07-01",
        "observed": 233,
        "expectedLow": 235.36821002785678,
        "expectedHigh": 396.8116912784171,
        "isSufficient": true
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      {
        "month": "2025-08-01",
        "observed": 215,
        "expectedLow": 155.1694602266371,
        "expectedHigh": 285.93240668881094,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 282,
        "expectedLow": 161.42121005792595,
        "expectedHigh": 298.80992717850773,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 393,
        "expectedLow": 169.83197553652286,
        "expectedHigh": 316.94272545121333,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 170,
        "expectedLow": 163.1496244104488,
        "expectedHigh": 357.6587174145374,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 206,
        "expectedLow": 144.7720962854604,
        "expectedHigh": 371.5031437959664,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 260,
        "expectedLow": 151.80811583834134,
        "expectedHigh": 410.78585280588817,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 196,
        "expectedLow": 124.50811087128338,
        "expectedHigh": 339.0893852777409,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 205,
        "expectedLow": 121.92674933342903,
        "expectedHigh": 363.6102471089263,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2702-2026, Z-1224-2026, Z-1225-2026, Z-1226-2026, Z-1227-2026). 1 first-time filer in the last 12 months, Medica USA, Inc (K243920). The code is crowded, scoring 71 of 100 — 77 companies hold a clearance here and 7 arrived in the last 12 months (KDI:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2702-2026",
          "Z-1224-2026",
          "Z-1225-2026",
          "Z-1226-2026",
          "Z-1227-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Medica USA, Inc.",
        "recordIds": [
          "K243920"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 71 of 100 — 77 companies hold a clearance here and 7 arrived in the last 12 months",
        "recordIds": [
          "KDI: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%3AKDI"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKDI"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKDI"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AKDI"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AKDI"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AKDI"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AKDI"
    }
  ],
  "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": "2026-08-11T13:51:45.730Z"
}