{
  "code": "GXY",
  "deviceName": "Electrode, Cutaneous",
  "deviceClass": "II",
  "regulationNumber": "882.1320",
  "panel": "Neurology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 439,
    "last12Months": 12
  },
  "adverseEvents": {
    "total": 145,
    "last12Months": 46
  },
  "reviewDays": {
    "median": 90,
    "sampleSize": 439
  },
  "recalls": {
    "total": 20,
    "recent": [
      {
        "resNumber": "Z-0203-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Coapt LLC",
        "firmAsPublished": "Coapt LLC",
        "reason": "Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.",
        "initiated": "2023-10-02"
      },
      {
        "resNumber": "Z-0204-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Coapt LLC",
        "firmAsPublished": "Coapt LLC",
        "reason": "Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.",
        "initiated": "2023-10-02"
      },
      {
        "resNumber": "Z-1595-2022",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
        "firmAsPublished": "Mckesson Medical-Surgical Inc. Corporate Office",
        "reason": "Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.",
        "initiated": "2022-05-25"
      },
      {
        "resNumber": "Z-1091-2022",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Neuralynx, Inc.",
        "firmAsPublished": "Neuralynx Inc",
        "reason": "Atlas Stim Headbox (ASHB) was delivered to US customers  under a premise that the device had an Investigational Device Exemption (IDE) and was for research use only, but the manufacturer  does not have an approved IDE by the FDA. The product has not undergone electrical safety testing and has not received regulatory clearance.",
        "initiated": "2022-03-14"
      },
      {
        "resNumber": "Z-1583-2014",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Medtronic Navigation, Inc.",
        "firmAsPublished": "Medtronic Navigation, Inc.",
        "reason": "Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.",
        "initiated": "2014-04-24"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K260578",
      "deviceName": "Ambu® NeurolineTM Cup MRI/CT  (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set  (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set  (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)",
      "applicant": "Ambu A/S",
      "company": "Ambu A/S",
      "decisionDate": "2026-07-14",
      "dateReceived": "2026-02-20"
    },
    {
      "kNumber": "K261442",
      "deviceName": "Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array",
      "applicant": "Cadwell Industries, Inc.",
      "company": "Cadwell Industries Inc",
      "decisionDate": "2026-06-26",
      "dateReceived": "2026-04-30"
    },
    {
      "kNumber": "K261522",
      "deviceName": "BioWave BioWraps",
      "applicant": "Biowave Corporation",
      "company": "Biowave Corporation",
      "decisionDate": "2026-06-03",
      "dateReceived": "2026-05-07"
    },
    {
      "kNumber": "K253237",
      "deviceName": "Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)",
      "applicant": "Elde Medikal Sanayi ve Ticaret Anonim Sirketi",
      "company": "Elde Medikal Sanayi ve Ticaret Anonim Sirketi",
      "decisionDate": "2026-05-08",
      "dateReceived": "2025-09-29"
    },
    {
      "kNumber": "K254183",
      "deviceName": "MR Conditional Cup Electrodes",
      "applicant": "Technomed Europe",
      "company": "Technomed Europe",
      "decisionDate": "2026-05-07",
      "dateReceived": "2025-12-23"
    },
    {
      "kNumber": "K252439",
      "deviceName": "Tutamen Self Adhesive Electrodes",
      "applicant": "Dongguan Tutamen Metalwork Co., Ltd.",
      "company": "Dongguan Tutamen Metalwork Co., Ltd.",
      "decisionDate": "2026-05-01",
      "dateReceived": "2025-08-04"
    },
    {
      "kNumber": "K253256",
      "deviceName": "myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)",
      "applicant": "Otto Bock Healthcare Products GmbH",
      "company": "Otto Bock Healthcare Products GmbH",
      "decisionDate": "2026-04-22",
      "dateReceived": "2025-09-29"
    },
    {
      "kNumber": "K260363",
      "deviceName": "Ceribell Brain Monitor Headband",
      "applicant": "Ceribell, Inc.",
      "company": "Ceribell, Inc.",
      "decisionDate": "2026-04-03",
      "dateReceived": "2026-02-04"
    },
    {
      "kNumber": "K260453",
      "deviceName": "Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)",
      "applicant": "Bionit Labs Srl",
      "company": "Bionit Labs Srl",
      "decisionDate": "2026-03-12",
      "dateReceived": "2026-02-11"
    },
    {
      "kNumber": "K254033",
      "deviceName": "Ceribell Instant EEG Headset",
      "applicant": "Ceribell, Inc.",
      "company": "Ceribell, Inc.",
      "decisionDate": "2026-02-09",
      "dateReceived": "2025-12-16"
    }
  ],
  "topApplicants": [
    {
      "name": "Empi",
      "count": 10
    },
    {
      "name": "Medtronic Vascular",
      "count": 10
    },
    {
      "name": "Aspect Medical Systems, Inc.",
      "count": 9
    },
    {
      "name": "Labeltape Meditect, Inc.",
      "count": 9
    },
    {
      "name": "Axelgaard Mfg. Co., Ltd.",
      "count": 8
    }
  ],
  "topCompanies": [
    {
      "name": "Empi",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Medtronic Vascular",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Aspect Medical Systems, Inc.",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Labeltape Meditect, Inc.",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Axelgaard Mfg. Co., Ltd.",
      "count": 8,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Ambu A/S",
      "since": "2026-07-14",
      "kNumber": "K260578"
    },
    {
      "name": "Cadwell Industries Inc",
      "since": "2026-06-26",
      "kNumber": "K261442"
    },
    {
      "name": "Elde Medikal Sanayi ve Ticaret Anonim Sirketi",
      "since": "2026-05-08",
      "kNumber": "K253237"
    },
    {
      "name": "Dongguan Tutamen Metalwork Co., Ltd.",
      "since": "2026-05-01",
      "kNumber": "K252439"
    },
    {
      "name": "Baisheng Medical Co., Ltd.",
      "since": "2025-08-13",
      "kNumber": "K250841"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 5,
        "expectedLow": 0.5136371350099082,
        "expectedHigh": 7.993394204664744,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 3,
        "expectedLow": 0.7289415282014018,
        "expectedHigh": 7.049584394639485,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 7,
        "expectedLow": 0.5065192798817166,
        "expectedHigh": 7.494695176952977,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 6,
        "expectedLow": 1.5079481670714894,
        "expectedHigh": 8.735716412553002,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 2,
        "expectedLow": 1.5639747169156142,
        "expectedHigh": 8.526501411416024,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 4,
        "expectedLow": 0.40513438701252413,
        "expectedHigh": 8.062821854250304,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 3,
        "expectedLow": 1.4381517038796552,
        "expectedHigh": 11.835478055146949,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 8.379490594097247,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 8,
        "expectedLow": 0,
        "expectedHigh": 8.42601723070914,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 9,
        "expectedLow": 0.3118739482677147,
        "expectedHigh": 9.730531888225844,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 5,
        "expectedLow": 1.1699772119421865,
        "expectedHigh": 9.934853279621617,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 3,
        "expectedLow": 1.1609219079412367,
        "expectedHigh": 10.803527078090884,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 6,
        "expectedLow": 0.07066123792688303,
        "expectedHigh": 11.690077494125608,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 3,
        "expectedLow": 0.08731773667727127,
        "expectedHigh": 9.871006854075496,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 10,
        "expectedLow": 0,
        "expectedHigh": 10.370790618996272,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "GXY (Electrode, Cutaneous) has three findings, most consequential first. 5 first-time filers in the last 12 months, including Ambu A/S and Cadwell Industries Inc (K260578, K261442, K253237, K252439, K250841). Clearances are running 50% slower — a median 135 days over the last 12 months against 90 days all-time (elapsed calendar days, not FDA review days) (GXY:review_time:12m). The code is crowded, scoring 97 of 100 — 251 companies hold a clearance here and 12 arrived in the last 12 months (GXY:crowding).",
    "severity": 45,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "5 first-time filers in the last 12 months, including Ambu A/S and Cadwell Industries Inc",
        "recordIds": [
          "K260578",
          "K261442",
          "K253237",
          "K252439",
          "K250841"
        ],
        "severity": 45
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 50% slower — a median 135 days over the last 12 months against 90 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "GXY:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 97 of 100 — 251 companies hold a clearance here and 12 arrived in the last 12 months",
        "recordIds": [
          "GXY: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%3AGXY"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AGXY"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AGXY"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AGXY"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AGXY"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AGXY"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AGXY"
    }
  ],
  "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": "2026-08-11T13:51:45.705Z"
}