{
  "openapi": "3.0.1",
  "info": {
    "title": "FDA 510(k) Premarket Clearances Scraper",
    "description": "Scrape FDA 510(k) premarket clearances from the official openFDA database. Filter by device, applicant, product code, medical specialty, state, country, clearance type and decision date. Enrich with device class and regulation. Export JSON, CSV, Excel.",
    "version": "0.1",
    "x-build-id": "rrEZX4rgl2m61pRNr"
  },
  "servers": [
    {
      "url": "https://api.apify.com/v2"
    }
  ],
  "paths": {
    "/acts/scrapers_lat~fda-510k-clearances-scraper/run-sync-get-dataset-items": {
      "post": {
        "operationId": "run-sync-get-dataset-items-scrapers_lat-fda-510k-clearances-scraper",
        "x-openai-isConsequential": false,
        "summary": "Executes an Actor, waits for its completion, and returns Actor's dataset items in response.",
        "tags": [
          "Run Actor"
        ],
        "requestBody": {
          "required": true,
          "content": {
            "application/json": {
              "schema": {
                "$ref": "#/components/schemas/inputSchema"
              }
            }
          }
        },
        "parameters": [
          {
            "name": "token",
            "in": "query",
            "required": true,
            "schema": {
              "type": "string"
            },
            "description": "Enter your Apify token here"
          }
        ],
        "responses": {
          "200": {
            "description": "OK"
          }
        }
      }
    },
    "/acts/scrapers_lat~fda-510k-clearances-scraper/runs": {
      "post": {
        "operationId": "runs-sync-scrapers_lat-fda-510k-clearances-scraper",
        "x-openai-isConsequential": false,
        "summary": "Executes an Actor and returns information about the initiated run in response.",
        "tags": [
          "Run Actor"
        ],
        "requestBody": {
          "required": true,
          "content": {
            "application/json": {
              "schema": {
                "$ref": "#/components/schemas/inputSchema"
              }
            }
          }
        },
        "parameters": [
          {
            "name": "token",
            "in": "query",
            "required": true,
            "schema": {
              "type": "string"
            },
            "description": "Enter your Apify token here"
          }
        ],
        "responses": {
          "200": {
            "description": "OK",
            "content": {
              "application/json": {
                "schema": {
                  "$ref": "#/components/schemas/runsResponseSchema"
                }
              }
            }
          }
        }
      }
    },
    "/acts/scrapers_lat~fda-510k-clearances-scraper/run-sync": {
      "post": {
        "operationId": "run-sync-scrapers_lat-fda-510k-clearances-scraper",
        "x-openai-isConsequential": false,
        "summary": "Executes an Actor, waits for completion, and returns the OUTPUT from Key-value store in response.",
        "tags": [
          "Run Actor"
        ],
        "requestBody": {
          "required": true,
          "content": {
            "application/json": {
              "schema": {
                "$ref": "#/components/schemas/inputSchema"
              }
            }
          }
        },
        "parameters": [
          {
            "name": "token",
            "in": "query",
            "required": true,
            "schema": {
              "type": "string"
            },
            "description": "Enter your Apify token here"
          }
        ],
        "responses": {
          "200": {
            "description": "OK"
          }
        }
      }
    }
  },
  "components": {
    "schemas": {
      "inputSchema": {
        "type": "object",
        "properties": {
          "deviceName": {
            "title": "Device Name",
            "type": "string",
            "description": "Match the cleared device trade / brand name, for example insulin pump or catheter. Matched as an exact phrase against the 510(k) device name."
          },
          "applicant": {
            "title": "Applicant (Company)",
            "type": "string",
            "description": "Match the company that submitted the 510(k), for example Medtronic or Abbott. Matched as an exact phrase against the applicant name."
          },
          "productCode": {
            "title": "Product Code",
            "type": "string",
            "description": "FDA three-letter product code, for example DQY or LWS. Identifies the device type / classification."
          },
          "advisoryCommittee": {
            "title": "Advisory Committee / Medical Specialty",
            "type": "string",
            "description": "Medical specialty. Enter a specialty description such as Cardiovascular, Orthopedic or Radiology, or a two-letter committee code such as CV or OR."
          },
          "state": {
            "title": "Applicant State",
            "type": "string",
            "description": "Two-letter US state code of the applicant, for example CA or MA."
          },
          "countryCode": {
            "title": "Applicant Country Code",
            "type": "string",
            "description": "Two-letter ISO country code of the applicant, for example US, DE or CN."
          },
          "clearanceType": {
            "title": "Clearance Type",
            "type": "string",
            "description": "510(k) review track, for example Traditional, Special or Abbreviated."
          },
          "decisionFrom": {
            "title": "Decision Date From",
            "type": "string",
            "description": "Only include clearances with a decision date on or after this date (YYYY-MM-DD)."
          },
          "decisionTo": {
            "title": "Decision Date To",
            "type": "string",
            "description": "Only include clearances with a decision date on or before this date (YYYY-MM-DD)."
          },
          "expeditedOnly": {
            "title": "Expedited Review Only",
            "type": "boolean",
            "description": "Only include clearances that went through expedited review.",
            "default": false
          },
          "thirdPartyOnly": {
            "title": "Third-Party Review Only",
            "type": "boolean",
            "description": "Only include clearances reviewed by an accredited third-party review organization.",
            "default": false
          },
          "searchQuery": {
            "title": "Raw openFDA Query (advanced)",
            "type": "string",
            "description": "Power users: a raw openFDA search expression that is combined (AND) with the filters above, for example decision_code:SESE or applicant:Boston."
          },
          "withApplicantProfile": {
            "title": "Add applicant regulatory profile (paid add-on)",
            "type": "boolean",
            "description": "Opt-in paid add-on. For each clearance, makes extra openFDA calls to build the applicant's regulatory profile: total and 5 most recent 510(k) clearances by the same company, plus any linked device recalls (count and 5 most recent). Adds supplier due-diligence value. Billed at $0.012 per clearance, only when the profile is built. Disabled for free Apify plans.",
            "default": false
          },
          "withAiSummary": {
            "title": "Add AI plain-English summary (paid add-on)",
            "type": "boolean",
            "description": "Opt-in paid add-on that uses AI to write a concise plain-English summary of each clearance (what the device is, its intended use and specialty, and the decision) for non-expert buyers. Billed at $0.012 per clearance, only when a usable summary is produced. Disabled for free Apify plans.",
            "default": false
          },
          "sort": {
            "title": "Sort",
            "type": "string",
            "description": "openFDA sort expression. Defaults to newest decisions first.",
            "default": "decision_date:desc"
          },
          "maxResults": {
            "title": "Max Results",
            "minimum": 1,
            "maximum": 1000000,
            "type": "integer",
            "description": "Maximum number of clearances to collect. openFDA paginates with skip up to 25000, so for very large pulls narrow the filters or the date range. Free Apify plans are capped at 10 per run."
          },
          "proxyConfiguration": {
            "title": "Proxy Configuration",
            "type": "object",
            "description": "Optional. openFDA is an open API and needs no proxy, but you can route requests through an Apify proxy if you prefer.",
            "default": {
              "useApifyProxy": false
            }
          }
        }
      },
      "runsResponseSchema": {
        "type": "object",
        "properties": {
          "data": {
            "type": "object",
            "properties": {
              "id": {
                "type": "string"
              },
              "actId": {
                "type": "string"
              },
              "userId": {
                "type": "string"
              },
              "startedAt": {
                "type": "string",
                "format": "date-time",
                "example": "2025-01-08T00:00:00.000Z"
              },
              "finishedAt": {
                "type": "string",
                "format": "date-time",
                "example": "2025-01-08T00:00:00.000Z"
              },
              "status": {
                "type": "string",
                "example": "READY"
              },
              "meta": {
                "type": "object",
                "properties": {
                  "origin": {
                    "type": "string",
                    "example": "API"
                  },
                  "userAgent": {
                    "type": "string"
                  }
                }
              },
              "stats": {
                "type": "object",
                "properties": {
                  "inputBodyLen": {
                    "type": "integer",
                    "example": 2000
                  },
                  "rebootCount": {
                    "type": "integer",
                    "example": 0
                  },
                  "restartCount": {
                    "type": "integer",
                    "example": 0
                  },
                  "resurrectCount": {
                    "type": "integer",
                    "example": 0
                  },
                  "computeUnits": {
                    "type": "integer",
                    "example": 0
                  }
                }
              },
              "options": {
                "type": "object",
                "properties": {
                  "build": {
                    "type": "string",
                    "example": "latest"
                  },
                  "timeoutSecs": {
                    "type": "integer",
                    "example": 300
                  },
                  "memoryMbytes": {
                    "type": "integer",
                    "example": 1024
                  },
                  "diskMbytes": {
                    "type": "integer",
                    "example": 2048
                  }
                }
              },
              "buildId": {
                "type": "string"
              },
              "defaultKeyValueStoreId": {
                "type": "string"
              },
              "defaultDatasetId": {
                "type": "string"
              },
              "defaultRequestQueueId": {
                "type": "string"
              },
              "buildNumber": {
                "type": "string",
                "example": "1.0.0"
              },
              "containerUrl": {
                "type": "string"
              },
              "usage": {
                "type": "object",
                "properties": {
                  "ACTOR_COMPUTE_UNITS": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATASET_READS": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATASET_WRITES": {
                    "type": "integer",
                    "example": 0
                  },
                  "KEY_VALUE_STORE_READS": {
                    "type": "integer",
                    "example": 0
                  },
                  "KEY_VALUE_STORE_WRITES": {
                    "type": "integer",
                    "example": 1
                  },
                  "KEY_VALUE_STORE_LISTS": {
                    "type": "integer",
                    "example": 0
                  },
                  "REQUEST_QUEUE_READS": {
                    "type": "integer",
                    "example": 0
                  },
                  "REQUEST_QUEUE_WRITES": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATA_TRANSFER_INTERNAL_GBYTES": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATA_TRANSFER_EXTERNAL_GBYTES": {
                    "type": "integer",
                    "example": 0
                  },
                  "PROXY_RESIDENTIAL_TRANSFER_GBYTES": {
                    "type": "integer",
                    "example": 0
                  },
                  "PROXY_SERPS": {
                    "type": "integer",
                    "example": 0
                  }
                }
              },
              "usageTotalUsd": {
                "type": "number",
                "example": 0.00005
              },
              "usageUsd": {
                "type": "object",
                "properties": {
                  "ACTOR_COMPUTE_UNITS": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATASET_READS": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATASET_WRITES": {
                    "type": "integer",
                    "example": 0
                  },
                  "KEY_VALUE_STORE_READS": {
                    "type": "integer",
                    "example": 0
                  },
                  "KEY_VALUE_STORE_WRITES": {
                    "type": "number",
                    "example": 0.00005
                  },
                  "KEY_VALUE_STORE_LISTS": {
                    "type": "integer",
                    "example": 0
                  },
                  "REQUEST_QUEUE_READS": {
                    "type": "integer",
                    "example": 0
                  },
                  "REQUEST_QUEUE_WRITES": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATA_TRANSFER_INTERNAL_GBYTES": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATA_TRANSFER_EXTERNAL_GBYTES": {
                    "type": "integer",
                    "example": 0
                  },
                  "PROXY_RESIDENTIAL_TRANSFER_GBYTES": {
                    "type": "integer",
                    "example": 0
                  },
                  "PROXY_SERPS": {
                    "type": "integer",
                    "example": 0
                  }
                }
              }
            }
          }
        }
      }
    }
  }
}