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fda_search_510k

Active

Tool of FDA Data MCP

declared in 0.1.0

Search FDA 510(k) clearances across all companies. Filter by company name (fuzzy match), product code, decision code (e.g., SESE=substantially equivalent), clearance type (Traditional, Special, Abbreviated), and date range. Returns clearance number (K-number), applicant, device name, decision date, and product code. Related: fda_device_class (product code details and classification), fda_product_code_lookup (cross-reference a product code across 510(k) and PMA), fda_search_pma (PMA approvals for higher-risk devices).

Parameters schema

{
  "type": "object",
  "$schema": "http://json-schema.org/draft-07/schema#",
  "properties": {
    "limit": {
      "type": "integer",
      "default": 100,
      "maximum": 500,
      "minimum": 1,
      "description": "Max results to return (1-500)"
    },
    "offset": {
      "type": "integer",
      "default": 0,
      "maximum": 9007199254740991,
      "minimum": 0,
      "description": "Result offset for pagination"
    },
    "company": {
      "type": "string",
      "maxLength": 500,
      "description": "Company name (fuzzy search)"
    },
    "to_date": {
      "type": "string",
      "pattern": "^\\d{4}-\\d{2}-\\d{2}$",
      "description": "End date for decision_date range (YYYY-MM-DD)"
    },
    "from_date": {
      "type": "string",
      "pattern": "^\\d{4}-\\d{2}-\\d{2}$",
      "description": "Start date for decision_date range (YYYY-MM-DD)"
    },
    "product_code": {
      "type": "string",
      "pattern": "^[A-Z]{2,3}$",
      "maxLength": 5,
      "description": "Device product code"
    },
    "decision_code": {
      "type": "string",
      "maxLength": 500,
      "description": "Decision code (e.g., SESE, SESD)"
    },
    "clearance_type": {
      "type": "string",
      "maxLength": 500,
      "description": "Clearance type (e.g., Traditional, Special)"
    }
  }
}

What this tool wraps· 0 endpoints

min confidence0.700.50

No endpoints wrapped at confidence ≥ 0.70.

Parent server

FDA Data MCP

https://github.com/medley/fda-data

1/7 registries
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fda_search_510k — FDA Data MCP — PRSM MCP