{
  "format": "devicerts.device.v1",
  "cite_as": "MONARCH Platform (MON-000008), Auris Health, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/monarch-platform-mon-000008-eoq (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/monarch-platform-mon-000008-eoq",
    "json_url": "https://devicerts.com/devices/monarch-platform-mon-000008-eoq.json",
    "markdown_url": "https://devicerts.com/devices/monarch-platform-mon-000008-eoq.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "registry_records_last_synced": "2026-11-08",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/monarch-platform-mon-000008-eoq",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "MONARCH Platform (MON-000008)",
    "registry_name": "MONARCH™ Platform (MON-000008)",
    "url": "https://devicerts.com/devices/monarch-platform-mon-000008-eoq",
    "manufacturer": {
      "name": "Auris Health, Inc.",
      "url": "https://devicerts.com/manufacturers/auris-health-inc",
      "country": "United States",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K243219",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "EOQ"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Monarch Platform (MON-000008) is a robotic, electromechanical, flexible bronchoscopy system designed for bronchoscopic visualization and access to patient airways. It functions as a Class 2 Ear, Nose, and Throat device, enabling diagnostic and therapeutic procedures within the respiratory tract.\n\nThis device is supplied as a reusable medical system and is regulated under FDA 510(k) clearance (K243219) via the Traditional pathway. Cleared for use in clinical settings, it adheres to Ear, Nose, and Throat product code EOQ standards and was reviewed by the Ear, Nose, Throat Advisory Committee.",
      "ai_generated": true,
      "generated_on": "2026-09-19",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K243219",
      "number_label": null,
      "device_udi_di": null,
      "date": "2025-01-23",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [
    {
      "number": "Z-1383-2026",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2026-01-21",
      "reason": "Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.",
      "applies": "this device",
      "via": "K243219"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K243219",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "EOQ",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 874.4680",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Ear, Nose, Throat",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}