{
  "companyId": "47650",
  "slug": "baxter-healthcare-corporation-47650",
  "name": "Baxter Healthcare Corporation",
  "clearances": {
    "total": 568,
    "last12Months": 1,
    "first": "1977-01-06",
    "latest": "2025-12-16"
  },
  "medianReviewDays": 85,
  "productCodeCount": 188,
  "recalls": {
    "total": 745,
    "openLast12Months": 28,
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      {
        "resNumber": "Z-2548-2026",
        "productCode": "NHJ",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2026-05-21",
        "reason": "There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits.  The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup."
      },
      {
        "resNumber": "Z-2549-2026",
        "productCode": "NHJ",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2026-05-21",
        "reason": "There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits.  The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup."
      },
      {
        "resNumber": "Z-2550-2026",
        "productCode": "NHJ",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2026-05-21",
        "reason": "There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits.  The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup."
      },
      {
        "resNumber": "Z-2551-2026",
        "productCode": "NHJ",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2026-05-21",
        "reason": "There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits.  The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup."
      },
      {
        "resNumber": "Z-2262-2026",
        "productCode": "NEP",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-04-22",
        "reason": "Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system alarms. This issue may lead to clinical effects such as\nelectrolyte imbalance, metabolic instability, delayed recovery, etc."
      }
    ]
  },
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    "sites": 6,
    "countries": [
      "US"
    ]
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      "code": "FPA",
      "deviceName": "Set, Administration, Intravascular",
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      "latest": "2025-03-14",
      "medianReviewDays": 78
    },
    {
      "code": "FRN",
      "deviceName": "Pump, Infusion",
      "clearances": 51,
      "latest": "2025-07-28",
      "medianReviewDays": 74
    },
    {
      "code": "KDI",
      "deviceName": "Dialyzer, High Permeability With Or Without Sealed Dialysate System",
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      "latest": "2023-09-14",
      "medianReviewDays": 108
    },
    {
      "code": "KDJ",
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      "code": "LHI",
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      "latest": "2014-11-19",
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    },
    {
      "code": "JJY",
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      "code": "MQV",
      "deviceName": "Filler, Bone Void, Calcium Compound",
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    {
      "code": "FJI",
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    {
      "code": "HET",
      "deviceName": "Laparoscope, Gynecologic (And Accessories)",
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      "latest": "1995-01-06",
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    },
    {
      "code": "FMI",
      "deviceName": "Needle, Hypodermic, Single Lumen",
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      "medianReviewDays": 87
    },
    {
      "code": "KPE",
      "deviceName": "Container, I.V.",
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      "latest": "2011-06-14",
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    {
      "code": "MEB",
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      "medianReviewDays": 59
    },
    {
      "code": "DYG",
      "deviceName": "Catheter, Flow Directed",
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      "medianReviewDays": 112
    },
    {
      "code": "FKX",
      "deviceName": "System, Peritoneal, Automatic Delivery",
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      "latest": "2020-11-19",
      "medianReviewDays": 135
    },
    {
      "code": "JWY",
      "deviceName": "Manual Antimicrobial Susceptibility Test Systems",
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      "latest": "1992-12-11",
      "medianReviewDays": 71
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    {
      "code": "KPO",
      "deviceName": "Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",
      "clearances": 7,
      "latest": "2017-01-06",
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    },
    {
      "code": "FMF",
      "deviceName": "Syringe, Piston",
      "clearances": 6,
      "latest": "2002-06-24",
      "medianReviewDays": 89
    },
    {
      "code": "FYA",
      "deviceName": "Gown, Surgical",
      "clearances": 6,
      "latest": "1996-10-28",
      "medianReviewDays": 118
    },
    {
      "code": "GGP",
      "deviceName": "Test, Qualitative And Quantitative Factor Deficiency",
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      "latest": "1991-02-26",
      "medianReviewDays": 60
    },
    {
      "code": "DQO",
      "deviceName": "Catheter, Intravascular, Diagnostic",
      "clearances": 5,
      "latest": "1992-09-21",
      "medianReviewDays": 98
    },
    {
      "code": "DTN",
      "deviceName": "Reservoir, Blood, Cardiopulmonary Bypass",
      "clearances": 5,
      "latest": "1998-01-22",
      "medianReviewDays": 190
    },
    {
      "code": "FOZ",
      "deviceName": "Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days",
      "clearances": 5,
      "latest": "2000-12-04",
      "medianReviewDays": 98
    },
    {
      "code": "GCJ",
      "deviceName": "Laparoscope, General & Plastic Surgery",
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      "latest": "2003-09-05",
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    },
    {
      "code": "KGO",
      "deviceName": "Surgeon'S Gloves",
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      "latest": "1994-07-05",
      "medianReviewDays": 49
    },
    {
      "code": "KKX",
      "deviceName": "Drape, Surgical, Antimicrobial",
      "clearances": 5,
      "latest": "1994-11-07",
      "medianReviewDays": 74
    }
  ],
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  "productCodesTotal": "188",
  "recentClearances": [
    {
      "kNumber": "K251745",
      "deviceName": "Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)",
      "productCode": "DXQ",
      "decisionDate": "2025-12-16",
      "reviewDays": 193
    },
    {
      "kNumber": "K251640",
      "deviceName": "SIGMA Spectrum Infusion Pump with Master Drug Library",
      "productCode": "FRN",
      "decisionDate": "2025-07-28",
      "reviewDays": 60
    },
    {
      "kNumber": "K251636",
      "deviceName": "Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)",
      "productCode": "FRN",
      "decisionDate": "2025-07-28",
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    {
      "kNumber": "K243529",
      "deviceName": "Solution Administration Sets",
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    },
    {
      "kNumber": "K242339",
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    {
      "kNumber": "K242390",
      "deviceName": "Novum IQ Syringe Pump (40800BAXUS)",
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      "kNumber": "K241564",
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    {
      "kNumber": "K231849",
      "deviceName": "MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483",
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  ],
  "nameVariants": {
    "total": "13",
    "shown": [
      {
        "name": "BAXTER HEALTHCARE CORPORATION",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "BAXTER HEALTHCARE CORPORATION",
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      },
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      },
      {
        "name": "Baxter Healthcare Corp",
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      },
      {
        "name": "Baxter Healthcare Corp.",
        "dataset": "device/enforcement",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Baxter%20Healthcare%20Corporation%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Baxter%20Healthcare%20Corporation%22"
  },
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      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
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      "loadedAt": "2026-08-10T06:54:18Z",
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    {
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    {
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  ],
  "retrievedAt": "2026-08-11T14:48:53.021Z"
}