# FDA 510(k) Clearance Leads (New Medical Devices) (`open-data-tools-hq/fda-510k-clearance-leads`) Actor

Newly cleared U.S. medical devices from the official openFDA 510(k) API: applicant company, contact name, address, device name, product code, advisory committee, decision date. Filter by state, product code, specialty; monitor mode for medtech sales leads.

- **URL**: https://apify.com/open-data-tools-hq/fda-510k-clearance-leads.md
- **Developed by:** [Open Data Tools](https://apify.com/open-data-tools-hq) (community)
- **Security:** Limited permissions
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $3.00 / 1,000 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/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 510(k) Clearance Leads (New Medical Devices)

When FDA clears a 510(k), the applicant company just proved a new (or modified) device is substantially equivalent. That is a **high-intent medtech lead**: they need contract manufacturing, sterilization, packaging, labeling, reimbursement consulting, distributors, and capital.

This actor pulls **new clearances from the official openFDA 510(k) API** with applicant name, contact, address, device name, product code, and advisory committee.

### Who uses this

- Medtech CDMO / contract manufacturers and sterilizers
- Regulatory and reimbursement consultants
- Device distributors and sales agencies
- Investors and BD teams tracking competitive clearances
- Software/tools that alert sales teams to new K-numbers

### Why this actor

- **Official source**: openFDA `device/510k` (FDA). No key for normal volumes.
- **Lead-ready fields**: applicant, contact name, street address, city/state/ZIP.
- **Filters**: decision-date window, state, product code, advisory committee, clearance type, US-only, require contact.
- **Monitor mode**: `onlyNewSinceLastRun` for scheduled feeds.
- **Pay per result**.

### Input examples

**US clearances last 30 days in CA/MA/MN with a contact name:**

```json
{ "daysBack": 30, "states": ["CA", "MA", "MN"], "requireContact": true }
```

**Neurology (NE) devices, last 90 days:**

```json
{ "daysBack": 90, "advisoryCommittees": ["NE"], "maxResults": 500 }
```

### Legal

openFDA data is public; follow https://open.fda.gov/terms/ and https://open.fda.gov/license/. Do not present the data as FDA advice. Lawful B2B lead gen and research only.

# Actor input Schema

## `daysBack` (type: `integer`):

Clearances with decision_date in the last N days. Ignored when decisionFrom is set.

## `decisionFrom` (type: `string`):

Optional start of FDA decision_date range (YYYY-MM-DD).

## `decisionTo` (type: `string`):

Optional end of FDA decision_date range. Defaults to today.

## `keyword` (type: `string`):

Optional search against device_name or applicant.

## `states` (type: `array`):

Two-letter state codes of the applicant address. Empty = all.

## `productCodes` (type: `array`):

Optional FDA product codes (e.g. POM, GWQ).

## `advisoryCommittees` (type: `array`):

Optional advisory committee codes such as NE, CV, OR, GU.

## `clearanceTypes` (type: `array`):

Optional clearance types (traditional, special, abbreviated) lowercase.

## `usOnly` (type: `boolean`):

When true, keep only applicants with US/USA country code (or blank).

## `requireContact` (type: `boolean`):

Only return clearances that list a contact name.

## `onlyNewSinceLastRun` (type: `boolean`):

Monitor mode: skip K-numbers already delivered to this buyer.

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

Maximum number of clearances to return in this run.

## Actor input object example

```json
{
  "daysBack": 30,
  "states": [
    "CA",
    "MA",
    "MN"
  ],
  "usOnly": true,
  "requireContact": false,
  "onlyNewSinceLastRun": false,
  "maxResults": 200
}
```

# Actor output Schema

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

Default dataset items (overview view in Console).

# 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 = {
    "states": [
        "CA",
        "MA",
        "MN"
    ]
};

// Run the Actor and wait for it to finish
const run = await client.actor("open-data-tools-hq/fda-510k-clearance-leads").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 = { "states": [
        "CA",
        "MA",
        "MN",
    ] }

# Run the Actor and wait for it to finish
run = client.actor("open-data-tools-hq/fda-510k-clearance-leads").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 '{
  "states": [
    "CA",
    "MA",
    "MN"
  ]
}' |
apify call open-data-tools-hq/fda-510k-clearance-leads --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,open-data-tools-hq/fda-510k-clearance-leads"
        }
    }
}
```

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/dcdSxQ3g7mj1EG6rt/builds/QgnISY3RwaP3iLOXz/openapi.json