🏥 FDA MedTech & 510(k) Medical Device Clearance Tracker

Real-time intelligence on FDA 510(k) premarket medical device clearances, regulatory decision dates, medical specialty panels, and manufacturer pipelines. Built for MedTech regulatory affairs consultants, medical patent attorneys, biomedical investors, and competitive intelligence teams.

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💡 Why Choose This Actor?

Getting FDA 510(k) clearance is the critical commercial milestone for medical device commercialization. Traditional regulatory intelligence databases charge exorbitant recurring subscriptions for public FDA data:

Feature / Metric	Enterprise Regulatory Terminals (Clarivate / FDAzilla / MedTech Insight)	Manual FDA Search on CDRH	FDA MedTech 510(k) Clearance Tracker
Monthly Cost	$350 – $1,200 / month (Annual lock-in)	$0 but hours of tedious manual lookup	Pay-Per-Event ($0.0100 / clearance) (Zero commitment)
Data Freshness	Weekly / Monthly batch updates	Real-time	Real-time openFDA 510(k) direct sync
API & Webhook Integrations	Locked behind $10k+ enterprise tier	None	Instant API, JSON, CSV, Webhook & Slack exports
Automated Alerts	Static email digests	None	Automated Apify Scheduler (Daily alerts on competitor filings)
Free Trial	Sales call required	None	$5.00 Free Trial Credit (Up to 500 clearances free)

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🎯 Target Audiences & Core Use Cases

1. MedTech Regulatory Affairs & Quality Assurance (RA/QA):
   • Identify predicate devices (product_code and regulation_number) to fast-track your 510(k) submission strategy.
2. Medical Patent Attorneys & IP Counsel:
   • Perform comprehensive prior-art and freedom-to-operate searches on recently approved medical devices.
3. MedTech Competitor & Pipeline Monitoring:
   • Track device approvals from major players (Medtronic, Abbott, Stryker, Boston Scientific, Johnson & Johnson, Siemens Healthineers) the day they are cleared.
4. Healthcare Equity & Venture Capital Investors:
   • Track commercialization readiness of clinical stage medical device startups upon FDA premarket clearance.

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📥 Input Parameters

Parameter	Type	Default	Description
searchQuery	String	""	Search keyword in device name or technology (e.g. catheter, laser, implant, robotic, sensor).
applicant	String	""	Filter by medical device manufacturer name (e.g. Medtronic, Abbott, Boston Scientific, Stryker).
advisoryCommittee	Select	"All"	Medical specialty panel (e.g. Cardiovascular, Orthopedic, General, Plastic Surgery, Radiology, Neurology, All).
maxItems	Integer	50	Maximum number of clearance records to retrieve (up to 500).

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📤 Output Data Format (JSON Sample)

[
  {
    "k_number": "K262735",
    "device_name": "LINQ II Insertable Cardiac Monitor (ICM)",
    "applicant": "Medtronic, Inc.",
    "decision_date": "2026-08-28",
    "decision_description": "Substantially Equivalent (SESE)",
    "advisory_committee": "Cardiovascular",
    "product_code": "MXZ",
    "regulation_number": "870.2800",
    "statement_or_summary": "Summary",
    "fda_review_speed": "⚡ Fresh Clearance (< 90 Days)",
    "device_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262735",
    "scraped_at": "2026-09-08T04:36:00+00:00"
  }
]

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🐍 1-Click Python Integration

from apify_client import ApifyClient

# Initialize client with your Apify API Token
client = ApifyClient("YOUR_APIFY_TOKEN")

# Run FDA MedTech & 510(k) Medical Device Clearance Tracker
run = client.actor("robinworld/fda-medtech-device-clearance-tracker").call(
    run_input={
        "applicant": "Medtronic",
        "advisoryCommittee": "Cardiovascular",
        "maxItems": 25
    }
)

# Fetch clearance items from the default dataset
for item in client.dataset(run["defaultDatasetId"]).iterate_items():
    print(f"[{item['k_number']}] {item['applicant']}: {item['device_name']}")
    print(f"  👉 Decision: {item['decision_date']} | Status: {item['fda_review_speed']}")
    print(f"  🔗 FDA Record: {item['device_url']}")

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❓ Frequently Asked Questions (FAQ)

Q: What is a 510(k) clearance?

A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective (substantially equivalent) to a legally marketed device.

Q: Where does this data come from?

Data is queried directly via the official FDA CDRH (Center for Devices and Radiological Health) openFDA public API in real-time.