FDA 510(k) Medical Device Clearance Intelligence

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📋 Instant Sample Output (JSON Preview)

Fast, schema-compliant JSON format ready for automated pipelines (n8n, Make, Zapier, Clay):

[
  {
    "kNumber": "K240001",
    "deviceName": "Digital Diagnostic System",
    "applicant": "MedTech Corp",
    "decisionDate": "2026-09-10",
    "regulationNumber": "892.1680"
  }
]

⚡ Value Proposition: High-Agency Engineering vs Legacy Scrapers

Most data collection scrapers waste your budget by spinning up heavy headless browsers (Chrome/Puppeteer), demanding expensive $15/GB residential proxies, and crashing when layouts change.

FDA 510(k) Medical Device Clearance Intelligence is architected for production reliability:

• Zero Proxy Tax ($0.00): Executes via direct, hyper-optimized asynchronous HTTP/DNS connections in < 512MB RAM.
• Pay-Per-Event Predictability: You only pay for verified, delivered records ($0.003 / record).
• Zero-Charge-on-Error Guarantee: Upstream outages, empty deltas, or unresolvable targets emit diagnostic baseline records completely free ($0.00).
• Sub-5 Second Turnaround: Pure REST/HTTP pipelines deliver datasets in seconds rather than minutes.

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🤖 AI Agent & Model Context Protocol (MCP) Integration

This Actor is packaged as an AI-first tool compatible with Claude Desktop, Cursor IDE, Windsurf, and LangChain / CrewAI agentic workflows.

Agent Trigger Rule:

"Use this tool when the user requests extract approved medical device clearances, applicants, product codes, and clearance decisions from openfda. or needs structured JSON data for fda-510k-clearance-intelligence without browser overhead or manual cleanup."

Claude Desktop / Cursor claude_desktop_config.json Snippet:

{
  "mcpServers": {
    "fda-510k-clearance-intelligence": {
      "command": "npx",
      "args": ["-y", "@apify/mcp-server-apify"],
      "env": {
        "APIFY_TOKEN": "YOUR_APIFY_API_TOKEN"
      }
    }
  }
}

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💰 Unit Economics & Cost Comparison

Feature	FDA 510(k) Medical Device Clearance Intelligence	Traditional Puppeteer / Playwright Scraper
Residential Proxy Bandwidth	$0.00 (Zero Proxy Tax)	$12.00 – $25.00 / GB
Execution Memory Required	256MB – 512MB RAM	2048MB – 4096MB RAM
Pricing Model	$0.003 / record (Pay-Per-Event)	Monthly SaaS / Expensive Compute Runtime
Failure Billing Policy	Zero-Charge on Error ($0.00)	Billed for full runtime on crash
Execution Speed	2–5 Seconds	45–120 Seconds

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⚡ 1-Click Integration Blueprints

1. Sync Execution via cURL / REST API

Run the Actor synchronously and retrieve dataset records immediately in one HTTP call:

curl -X POST "https://api.apify.com/v2/acts/deepaksheoran172~fda-510k-clearance-intelligence/run-sync-get-dataset-items?token=YOUR_APIFY_TOKEN" \
  -H "Content-Type: application/json" \
  -d '{}'

2. Python (apify-client)

from apify_client import ApifyClient

client = ApifyClient("YOUR_APIFY_TOKEN")
run_input = {}

# Start Actor run and wait for completion
run = client.actor("deepaksheoran172/fda-510k-clearance-intelligence").call(run_input=run_input)

# Fetch structured dataset records
items = client.dataset(run["defaultDatasetId"]).list_items().items
for record in items:
    print(record)

3. n8n / Make.com Webhook Automation

• Node Type: HTTP Request Node
• Method: POST
• URL: https://api.apify.com/v2/acts/deepaksheoran172~fda-510k-clearance-intelligence/run-sync-get-dataset-items?token=YOUR_APIFY_TOKEN
• Headers: Content-Type: application/json
• Body: Raw JSON {}

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📥 Input Parameters

All properties feature built-in defaults; providing an empty object {} triggers a reliable default scan.

Parameter	Type	Default	Description
applicant	string	medtronic	Configures Applicant Name for the extraction execution. Provide a valid input matching expected parameters or leave default to run automated scan.
maxItems	integer	10	Maximum total records to extract and deliver to the output dataset during this run (for example 50 or 100 records) to govern compute time and data volume.

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📤 Output Dataset Specification

Output records strictly adhere to the official Apify dataset schema:

Field Name	Type	Description
kNumber	string	FDA 510(k) Number (e.g. K201234)
applicant	string	Applicant company name
deviceName	string	Commercial medical device name
decisionDate	string	FDA clearance decision date
decisionCode	string	FDA decision code (e.g. SESE)
productCode	string	FDA three-letter product code

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❓ Frequently Asked Questions (FAQ)

Q: How does Pay-Per-Event (PPE) pricing protect my budget?

A: Unlike compute-time billing where you pay while waiting for slow responses, Pay-Per-Event charges only for legitimate data rows delivered. If an upstream service is down, the Actor pushes a diagnostic status record and does not bill you.

Q: Can I run this on a recurring schedule?

A: Yes! Use Apify's built-in Scheduler (Cron), or trigger it via Zapier, Make.com, or n8n on a daily, weekly, or hourly cadence.

Q: Are external proxies or browser engines required?

A: No. All requests use lightweight, high-performance asynchronous HTTP networking. There is zero proxy markup and zero browser overhead.

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