# FDA 510k Device Clearance Monitor (`technicaldost/fda-device-510k-monitor`) Actor

Track recent medical device 510(k) clearances from openFDA.

- **URL**: https://apify.com/technicaldost/fda-device-510k-monitor.md
- **Developed by:** [Technical Dost Solutions](https://apify.com/technicaldost) (community)
- **Categories:** Developer tools, Automation
- **Stats:** 3 total users, 2 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $30.00 / 1,000 fda 510k clearance results

This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events.

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

## What's an Apify Actor?

Actors are web data automations that power AI and operations. They run on the Apify platform to scrape websites, process data, connect APIs, and automate workflows.
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.
Actors are written with capital "A".

## 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.
The best way to integrate Actors is as follows.

- **AI agents and MCP clients** — the [Apify MCP server](https://docs.apify.com/integrations/mcp.md) at `https://mcp.apify.com` (remote, streamable HTTP, OAuth on first use).
- **Agentic workflows and local Actor development** — [Agent Skills](https://apify.com/.well-known/agent-skills/index.json) with the [Apify CLI](https://docs.apify.com/cli/docs.md): `npm install -g apify-cli`, then `apify login`.
- **JavaScript/TypeScript projects** — the official [JS/TS client](https://docs.apify.com/api/client/js/docs.md): `npm install apify-client`.
- **Python projects** — the official [Python client](https://docs.apify.com/api/client/python/docs.md): `pip install apify-client`.
- **Any other language** — the [REST API](https://docs.apify.com/api/v2.md).

For usage examples, see the [API](#api) section below.

For more details, see Apify documentation as [Markdown index](https://docs.apify.com/llms.txt) and [Markdown full-text](https://docs.apify.com/llms-full.txt).

# README

## FDA 510k Device Clearance Monitor

![FDA 510k Device Clearance Monitor icon](.actor/icon.svg)

Track recent medical device 510(k) clearances from openFDA.

### Why this can sell

- Store gap checked: FDA 510k has low direct supply despite strong medtech buyer intent.
- Buyer intent is commercial: compliance, security, legal, regulatory, or competitive-intelligence workflows.
- The Actor uses stable public APIs or official public feeds, so it can run on schedules without expensive browser proxy overhead.

### Input

Run with the defaults for a sample dataset. Narrow the query fields for production monitoring.

### Output

The default dataset contains normalized records with these fields:

- `kNumber`
- `deviceName`
- `applicant`
- `decisionDate`
- `decisionCode`
- `productCode`
- `advisoryCommittee`
- `sourceUrl`

### Monetization

Best fit: pay per clearance row or monthly competitor-monitoring plans.

### Notes

This Actor is designed as a reliable data product, not a brittle webpage scraper. Always validate regulated or legal data against the linked source before making business decisions.

# Actor input Schema

## `deviceName` (type: `string`):

Device keyword for FDA 510k Device Clearance Monitor.

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

Applicant keyword for FDA 510k Device Clearance Monitor.

## `decisionAfter` (type: `string`):

Decision after for FDA 510k Device Clearance Monitor.

## `maxItems` (type: `integer`):

Maximum clearances for FDA 510k Device Clearance Monitor.

## Actor input object example

```json
{
  "deviceName": "glucose",
  "maxItems": 20
}
```

# 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 = {
    "deviceName": "glucose"
};

// Run the Actor and wait for it to finish
const run = await client.actor("technicaldost/fda-device-510k-monitor").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 = { "deviceName": "glucose" }

# Run the Actor and wait for it to finish
run = client.actor("technicaldost/fda-device-510k-monitor").call(run_input=run_input)

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

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

```

## CLI example

```bash
echo '{
  "deviceName": "glucose"
}' |
apify call technicaldost/fda-device-510k-monitor --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "command": "npx",
            "args": [
                "mcp-remote",
                "https://mcp.apify.com/?tools=technicaldost/fda-device-510k-monitor",
                "--header",
                "Authorization: Bearer <YOUR_API_TOKEN>"
            ]
        }
    }
}

```

## OpenAPI specification

Download the OpenAPI definition: https://api.apify.com/v2/actors/b2m4ASH5udWTI2pim/builds/M4nqekSncwqB15oBI/openapi.json