openFDA 510(k) Device Clearances Scraper

Export FDA 510(k) medical device clearance records from the public openFDA API.

Use this actor to monitor cleared medical devices, track competitors, build regulatory intelligence dashboards, or enrich compliance workflows with structured FDA 510(k) data.

What does openFDA 510(k) Device Clearances Scraper do?

This actor searches the openFDA device/510k dataset and saves normalized 510(k) clearance records to an Apify dataset.

It can export records by applicant, device name, product code, k-number, FDA decision date, received date, decision code, or a raw openFDA query.

Each output item includes normalized fields and direct links back to FDA and openFDA records.

Who is it for?

• 🏥 Medtech regulatory affairs teams monitoring new clearances in their product areas.
• 📊 Competitive intelligence analysts tracking competitors by applicant, product code, and clearance date.
• 💼 Investors and consultants researching device markets, clearance cadence, and sponsor activity.
• ⚖️ Compliance and product-liability teams reviewing historical FDA device clearance metadata.
• 🧪 Data teams building repeatable FDA data pipelines on Apify.

Why use this actor?

The openFDA API is public, but raw API calls require users to build query strings, paginate, normalize fields, and manage exports.

This actor turns the API into a ready-to-run Apify workflow with clean input fields, dataset export, API access, integrations, and pay-per-result pricing.

Key features

• 🔎 Search FDA 510(k) clearances by company, device, product code, or k-number.
• 📅 Filter by decision date and FDA received date.
• 🧾 Export normalized regulatory metadata.
• 🔗 Save direct FDA record URLs and openFDA API URLs.
• 🧰 Keep optional raw FDA JSON for audits.
• ⚡ HTTP-only implementation; no browser or proxy required.

Data table

Field	Description
kNumber	FDA 510(k) number such as K240001
applicant	Applicant or manufacturer name
deviceName	Cleared device name
productCode	FDA product code
decisionDate	FDA decision date
decisionDescription	Human-readable FDA decision description
clearanceType	Clearance type from openFDA
dateReceived	Date FDA received the submission
advisoryCommitteeDescription	Committee or medical specialty text
recordUrl	Direct FDA record page
apiUrl	Direct openFDA API URL for the record
raw	Optional original openFDA record

How much does it cost to scrape FDA 510(k) clearances?

The actor uses pay-per-event pricing:

• Run started: $0.005 once per run.
• 510(k) clearance record extracted: tiered per-record pricing, starting at $0.000025187 per saved record on the Free tier and decreasing on paid Apify plans.
• Higher Apify subscription tiers receive discounted per-record pricing.

Estimated actor charges on the Free tier:

Records exported	Estimated charge
20 records	~$0.0055
100 records	~$0.0075
150 records	~$0.0088

Free-plan estimate: with $5 of available Apify usage credit, 100-record runs would cover roughly 650 runs / 65,000 records at the current Free-tier actor price, before any separate Apify platform usage costs or account-level limits.

Because the source is a public API and the actor does not use a browser or proxy, runs are designed to stay inexpensive.

How to use it

1. Open the actor on Apify.
2. Enter a company name such as Medtronic in Applicant / company.
3. Optionally add a product code, device name, or date range.
4. Keep Maximum records low for a first test run.
5. Start the actor.
6. Download the dataset as JSON, CSV, Excel, XML, or HTML.

Input options

Raw openFDA search query

Use search when you already know openFDA query syntax.

Example:

applicant:"MEDTRONIC"+AND+product_code:"DQY"

Applicant / company

Filter by applicant name.

Examples:

• Medtronic
• Abbott
• Boston Scientific

Device name

Filter by device name text.

Examples:

• stent
• catheter
• implant

Product code

Filter by FDA product code.

Examples:

• DQY
• MNI
• OYC

510(k) number

Export one specific clearance by k-number.

Example:

{ "kNumber": "K240001" }

Date filters

Use decision-date filters for market monitoring and received-date filters for workflow analysis.

Dates can be entered as YYYY-MM-DD or YYYYMMDD.

Include raw FDA record

Enable includeRaw when you need every original openFDA field for validation, legal review, or custom downstream processing.

Output example

{
  "kNumber": "K240001",
  "applicant": "EXAMPLE MEDICAL INC.",
  "deviceName": "Example Device",
  "productCode": "ABC",
  "decisionDate": "20240115",
  "decisionDescription": "Substantially Equivalent",
  "dateReceived": "20231001",
  "recordUrl": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240001",
  "source": "openFDA device/510k"
}

Tips for better results

• ✅ Start with a company and date range before running large exports.
• ✅ Use product codes for focused market maps.
• ✅ Use k-number mode when you need one exact clearance.
• ✅ Enable raw records only when needed because it increases dataset size.
• ✅ Use recent decision dates for monitoring workflows.

Integrations

You can connect this actor to:

• Google Sheets for weekly clearance trackers.
• Airtable for medtech competitive intelligence.
• Slack or email alerts for new product-code clearances.
• BI tools for clearance timelines and applicant dashboards.
• Internal regulatory data lakes via the Apify API.

API usage

Node.js

import { ApifyClient } from 'apify-client';

const client = new ApifyClient({ token: process.env.APIFY_TOKEN });
const run = await client.actor('automation-lab/openfda-510k-device-clearances-scraper').call({
  applicant: 'Medtronic',
  decisionDateFrom: '2024-01-01',
  maxResults: 100,
});
console.log(run.defaultDatasetId);

Python

from apify_client import ApifyClient

client = ApifyClient('MY-APIFY-TOKEN')
run = client.actor('automation-lab/openfda-510k-device-clearances-scraper').call(run_input={
    'applicant': 'Medtronic',
    'decisionDateFrom': '2024-01-01',
    'maxResults': 100,
})
print(run['defaultDatasetId'])

cURL

curl "https://api.apify.com/v2/acts/automation-lab~openfda-510k-device-clearances-scraper/runs?token=$APIFY_TOKEN" \
  -H 'Content-Type: application/json' \
  -d '{"applicant":"Medtronic","decisionDateFrom":"2024-01-01","maxResults":100}'

MCP integration

Use the actor through Apify MCP from Claude Desktop, Claude Code, Cursor, VS Code, and other MCP clients.

MCP URL:

https://mcp.apify.com/?tools=automation-lab/openfda-510k-device-clearances-scraper

Claude Code setup:

$claude mcp add apify-openfda-510k --transport http "https://mcp.apify.com/?tools=automation-lab/openfda-510k-device-clearances-scraper"

Claude Desktop, Cursor, and VS Code JSON config:

{
  "mcpServers": {
    "apify-openfda-510k": {
      "url": "https://mcp.apify.com/?tools=automation-lab/openfda-510k-device-clearances-scraper"
    }
  }
}

Example prompts:

• "Export 100 recent FDA 510(k) clearances for Medtronic."
• "Find cleared devices for product code DQY since 2024."
• "Monitor new Abbott 510(k) decisions and summarize the device names."

Common workflows

Competitor monitoring

Run weekly with applicant filters for known competitors.

Product-code market mapping

Run by product code and decision date to understand clearance velocity.

Single-record enrichment

Run by k-number to enrich CRM, claims, or product-intelligence records.

Regulatory dashboard refresh

Schedule runs and export the dataset to BI or a data warehouse.

Limitations

• The actor depends on openFDA availability and openFDA query syntax.
• Very large whole-database exports may require multiple runs.
• Some FDA fields are sparse because the source record may omit them.
• The actor does not interpret legal meaning; it exports source metadata.

Legality

This actor uses the public openFDA API for FDA public records. Users are responsible for complying with applicable laws, internal policies, openFDA terms, and Apify terms.

The dataset may be used for research, monitoring, and analytics, but it should not be treated as legal, medical, or regulatory advice.

FAQ

Does it require an FDA API key?

No. The actor works with the public openFDA API without an API key for normal usage.

Does it use proxies?

No. The source is a public API, so the actor does not require a proxy by default.

Why did my query fail?

Raw openFDA queries must use valid openFDA search syntax. Try using the structured input fields first, then move to raw query mode.

Why are some fields empty?

The FDA source record does not always contain every field. Empty values usually mean the source omitted that metadata.

Related scrapers

• https://apify.com/automation-lab/fda-maude-adverse-event-reports-scraper
• https://apify.com/automation-lab/fda-orange-book-scraper
• https://apify.com/automation-lab/openfda-510k-device-clearances-scraper

Support

If you need an additional field, filter, or export format, open an issue on the actor page and include a sample k-number or query.

Changelog

Initial version exports normalized FDA 510(k) clearance records from openFDA.