# FDA Medical Devices 510(k) Intelligence Scraper (`litezero/openfda-medical-devices-scraper`) Actor

Extract official FDA 510(k) premarket clearance decisions, device classifications, applicants, product codes, regulation numbers, and clearance dates for MedTech intelligence.

- **URL**: https://apify.com/litezero/openfda-medical-devices-scraper.md
- **Developed by:** [LiteZero](https://apify.com/litezero) (community)
- **Categories:** Developer tools, Automation, AI
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $1.05 / 1,000 item scrapeds

This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events.
Since this Actor supports Apify Store discounts, the price gets lower the higher subscription plan you have.

Learn more: https://docs.apify.com/actors/running/actors-in-store.md#pay-per-event

## What's an Apify Actor?

An Actor is a serverless cloud program that runs on the Apify platform. It has two run modes.
In Batch mode, an Actor accepts a well-defined JSON input, performs an action which can take anything from a few seconds to a few hours,
and optionally produces a well-defined JSON output, datasets with results, or files in key-value store.
In Standby mode, an Actor provides a web server which can be used as a website, API, or an MCP server.

Apify vocabulary and the platform model are defined once, in the agent quickstart at https://apify.com/agents.md.

## How to integrate an Actor?

If asked about integration, you help developers integrate Actors into their projects.
You adapt to their stack and deliver integrations that are safe, well-documented, and production-ready.

Do not guess an integration path. Every one of them is in the agent quickstart at https://apify.com/agents.md: the Apify MCP server, Agent Skills with the Apify CLI, the JavaScript and Python clients, the REST API, and the account-free path for an agent with no human to sign in. It also carries the rule on stating cost before the first paid run.

For examples already wired to this Actor's own input schema, see the [API](#api) section below.

Each client library has reference documentation the quickstart does not restate: [JavaScript/TypeScript](https://docs.apify.com/api/client/js/docs.md) (`npm install apify-client`) and [Python](https://docs.apify.com/api/client/python/docs.md) (`pip install apify-client`).

# README

## 🏥 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.

***

### 🥊 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 |

***

### 🛠️ 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

```python
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

```javascript
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

```bash
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}'
```

***

### 📥 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). |

***

### 📤 Output Data Dictionary & Sample JSON

```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"
}
```

***

### 💡 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.

# Actor input Schema

## `searchQuery` (type: `string`):

Device name or keyword (e.g., 'laser', 'catheter', 'cardiac', 'stent').

## `applicant` (type: `string`):

Filter by manufacturer or applicant company name (optional).

## `deviceClass` (type: `string`):

Filter by FDA Device Class (1, 2, 3, or all).

## `maxResults` (type: `integer`):

Maximum number of clearance records to retrieve (1 to 100).

## Actor input object example

```json
{
  "searchQuery": "catheter",
  "applicant": "",
  "deviceClass": "all",
  "maxResults": 20
}
```

# Actor output Schema

## `results` (type: `string`):

No description

# API

You can run this Actor programmatically using our API. Below are code examples in JavaScript, Python, and CLI, as well as the OpenAPI specification and MCP server setup.

## JavaScript example

```javascript
import { ApifyClient } from 'apify-client';

// Initialize the ApifyClient with your Apify API token
// Replace the '<YOUR_API_TOKEN>' with your token
const client = new ApifyClient({
    token: '<YOUR_API_TOKEN>',
});

// Prepare Actor input
const input = {
    "searchQuery": "catheter",
    "applicant": "",
    "deviceClass": "all",
    "maxResults": 20
};

// Run the Actor and wait for it to finish
const run = await client.actor("litezero/openfda-medical-devices-scraper").call(input);

// Fetch and print Actor results from the run's dataset (if any)
console.log('Results from dataset');
console.log(`💾 Check your data here: https://console.apify.com/storage/datasets/${run.defaultDatasetId}`);
const { items } = await client.dataset(run.defaultDatasetId).listItems();
items.forEach((item) => {
    console.dir(item);
});

// 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/js/docs

```

## Python example

```python
from apify_client import ApifyClient

# Initialize the ApifyClient with your Apify API token
# Replace '<YOUR_API_TOKEN>' with your token.
client = ApifyClient("<YOUR_API_TOKEN>")

# Prepare the Actor input
run_input = {
    "searchQuery": "catheter",
    "applicant": "",
    "deviceClass": "all",
    "maxResults": 20,
}

# Run the Actor and wait for it to finish
run = client.actor("litezero/openfda-medical-devices-scraper").call(run_input=run_input)

# Fetch and print Actor results from the run's dataset (if there are any)
print(f"💾 Check your data here: https://console.apify.com/storage/datasets/{run.default_dataset_id}")
for item in client.dataset(run.default_dataset_id).iterate_items():
    print(item)

# 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start

```

## CLI example

```bash
echo '{
  "searchQuery": "catheter",
  "applicant": "",
  "deviceClass": "all",
  "maxResults": 20
}' |
apify call litezero/openfda-medical-devices-scraper --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,litezero/openfda-medical-devices-scraper"
        }
    }
}
```

The hosted server signs you in with OAuth on first connect, so no API token belongs in this config. Clients without OAuth support can send an `Authorization: Bearer <APIFY_API_TOKEN>` header instead, using a token from API & Integrations in Apify Console (https://console.apify.com/settings/integrations).

## OpenAPI specification

Download the OpenAPI definition: https://api.apify.com/v2/actors/tAlQwDfVPTBl6rfON/builds/I3zxVyBGJX9ufB0hC/openapi.json