🏥 FDA Medical Devices 510(k) Intelligence Scraper

Extract official FDA 510(k) premarket clearance decisions, device classifications, applicant manufacturers, regulation citations, and decision timelines from the US Food and Drug Administration database.

Engineered for MedTech regulatory affairs teams, patent attorneys, biotech competitive intelligence analysts, and medical device distributors.

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🥊 Why This Actor Beats the Competition

Feature	🏥 This Actor (litezero)	🐢 FDA CDRH Legacy Search	🔒 Enterprise MedTech SaaS
Speed	⚡ < 1.2 seconds / query	🐌 10–25s clumsy ASP.NET forms	⏳ Heavy API gateways
Pricing	💰 $1.50 / 1,000 clearances (Free Platform Usage)	💸 Manual data entry ($$$ labor)	💳 $500–$2,000 / month
Data Completeness	📦 Full 510(k) #, applicant, codes, regulation #	⚠️ Truncated tables & PDF scraping	🔒 Proprietary data lock-in
Automation	🤖 REST API, Python, Node.js, Webhooks	❌ Zero API access (CAPTCHA protected)	🛠️ Complex enterprise integration
Freshness	🔄 Direct openFDA real-time database	🗓️ Weekly batch updates	⏱️ Delayed sync

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🛠️ Step-by-Step: How to Use

Method 1: Apify Web Console (No-Code)

1. Enter your search term (e.g. catheter, stent, laser, cardiovascular, or surgical robot).
2. Optional: Filter by specific applicant (e.g. Medtronic, Boston Scientific, Abbott).
3. Click Start and export results to JSON, CSV, or Excel.

Method 2: Python SDK

from apify_client import ApifyClient

client = ApifyClient("YOUR_APIFY_TOKEN")
run_input = {
    "searchQuery": "catheter",
    "applicant": "Medtronic",
    "maxResults": 20
}

run = client.actor("litezero/openfda-medical-devices-scraper").call(run_input=run_input)
for item in client.dataset(run["defaultDatasetId"]).iterate_items():
    print(f"[{item['k_number']}] {item['device_name']} by {item['applicant']} ({item['decision_date']})")

Method 3: Node.js SDK

import { ApifyClient } from 'apify-client';

const client = new ApifyClient({ token: 'YOUR_APIFY_TOKEN' });
const run = await client.actor('litezero/openfda-medical-devices-scraper').call({
    searchQuery: 'laser',
    maxResults: 25
});

const { items } = await client.dataset(run.defaultDatasetId).listItems();
console.log(`Retrieved ${items.length} 510(k) clearances.`);

Method 4: REST API / cURL

curl "https://api.apify.com/v2/acts/litezero~openfda-medical-devices-scraper/runs?token=YOUR_APIFY_TOKEN" \
  -H "Content-Type: application/json" \
  -d '{"searchQuery": "endoscope", "maxResults": 10}'

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📥 Input Parameters

Parameter	Type	Required	Default	Description
searchQuery	string	Yes	"catheter"	Device name, medical specialty, or keywords.
applicant	string	No	""	Filter by manufacturer or applicant name.
deviceClass	string	No	"all"	Filter by FDA Device Class (1, 2, 3, or all).
maxResults	integer	No	20	Max clearance records to return (1–100).

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📤 Output Data Dictionary & Sample JSON

{
  "k_number": "K221852",
  "device_name": "Shockwave Intravascular Lithotripsy (IVL) System",
  "applicant": "Shockwave Medical, Inc.",
  "decision_date": "2022-09-15",
  "date_received": "2022-06-24",
  "decision_code": "SESE",
  "decision_description": "Substantially Equivalent",
  "clearance_type": "Dual Track / Traditional",
  "product_code": "PNX",
  "statement_or_summary": "Summary",
  "device_class": "2",
  "medical_specialty_description": "Cardiovascular",
  "regulation_number": "870.1250",
  "device_name_openfda": "Catheter, Percutaneous",
  "city": "Santa Clara",
  "state": "CA",
  "country_code": "US",
  "fda_database_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221852",
  "scraped_at": "2026-10-04T06:00:00.000Z"
}

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💡 Top Commercial Use Cases

1. MedTech Competitor Intelligence: Monitor new product clearances and 510(k) submissions by competing medical device manufacturers.
2. Regulatory & Quality Compliance: Track predicate devices, regulation numbers (CFR 21), and product codes for regulatory submission drafting.
3. Patent & M&A Due Diligence: Assess the active FDA clearance portfolio and historical clearance cadence of target MedTech acquisitions.