# FDA 510(k) & PMA Device Clearances: Medical Device Approvals (`tacps126/fda-device-clearances`) Actor

FDA medical device 510(k) clearances and PMA approvals: applicant, contact person, address, device and generic name, product code, specialty, device class, dates received and decided, review days, decision and links. Filters by date, company, device, product code, specialty, class; alerts.

- **URL**: https://apify.com/tacps126/fda-device-clearances.md
- **Developed by:** [Tapaswai Choudhary](https://apify.com/tacps126) (community)
- **Categories:** Lead generation, Automation
- **Security:** Limited permissions
- **Stats:** 1 total users, 0 monthly users, 0.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $3.20 / 1,000 decisions

This Actor is paid per event and usage. You are charged both the fixed price for specific events and for Apify platform usage.
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 510(k) & PMA Device Clearances — Medical Device Approvals

New **FDA medical device decisions** in one clean feed: **510(k) clearances** and **PMA approvals**, each with the applicant company, the **contact person** (510(k)), address, device and generic name, product code, review specialty, device class, dates received and decided, review time in days, decision and links to the FDA record and summary.

**Built for** medtech sales and business development (newly cleared devices = companies about to launch), regulatory consultants, contract manufacturers and component suppliers, investors and analysts, and AI agents.

### What you get

| Field | Meaning |
|---|---|
| `type`, `id`, `url`, `documentUrl` | 510(k) / PMA, its number and FDA links |
| `applicant`, `contact`, `street`, `city`, `state`, `zip`, `country` | Who got it and how to reach them |
| `deviceName`, `genericName`, `productCode`, `deviceClass`, `regulationNumber`, `specialty` | The device |
| `dateReceived`, `decisionDate`, `reviewDays`, `decision`, `submissionType` | The review |
| `approvalStatement`, `supplementReason` | PMA details |

### Why this Actor

- **Both pathways** in one schema, newest first.
- **Filters:** date window, company, device words, product codes, specialty, device class; PMA supplements on request.
- **Alerts:** *Only new decisions* on a weekly schedule.
- **For AI agents.** Callable as an MCP tool.

### How to use it

New cardiovascular and radiology clearances this month:

```json
{ "types": ["510k"], "decidedWithinDays": 30, "specialties": ["Cardiovascular", "Radiology"] }
```

### Pricing

**$4 per 1,000 decisions** plus a small start fee per run. On the Apify free plan a run returns up to 100 decisions.

### Good to know

- Data is as published by FDA through openFDA. Questions: **tacps126@gmail.com**.

# Actor input Schema

## `types` (type: `array`):

510(k): devices cleared as substantially equivalent. PMA: premarket approvals (class III).

## `decidedWithinDays` (type: `integer`):

About 250-300 510(k) decisions a month.

## `dateFrom` (type: `string`):

YYYY-MM-DD; with To date replaces the days above.

## `dateTo` (type: `string`):

YYYY-MM-DD (default today).

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

Applicant name, e.g. Medtronic.

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

Words in the device or trade name, e.g. catheter, stent, AI.

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

FDA three-letter product codes, e.g. QAS, LLZ.

## `specialties` (type: `array`):

FDA review panel.

## `deviceClasses` (type: `array`):

Empty = all.

## `includePmaSupplements` (type: `boolean`):

Also return changes to approved PMA devices (many are manufacturing or labelling changes).

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

Most decisions returned per run.

## `onlyNew` (type: `boolean`):

Schedule the Actor and each run returns only decisions earlier runs did not deliver.

## `monitorName` (type: `string`):

Optional name for the “only new” history, so several monitors can run side by side.

## `tenantId` (type: `string`):

Optional label used to keep separate histories for different clients or teams.

## `openFdaApiKey` (type: `string`):

Your free key from open.fda.gov raises the daily request limit for very large runs.

## `debug` (type: `boolean`):

Save extra diagnostics with the run (for support requests).

## Actor input object example

```json
{
  "types": [
    "510k",
    "pma"
  ],
  "decidedWithinDays": 30,
  "includePmaSupplements": false,
  "maxItems": 500,
  "onlyNew": false,
  "debug": false
}
```

# Actor output Schema

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

The produced items (default dataset items).

# 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 = {
    "types": [
        "510k",
        "pma"
    ]
};

// Run the Actor and wait for it to finish
const run = await client.actor("tacps126/fda-device-clearances").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 = { "types": [
        "510k",
        "pma",
    ] }

# Run the Actor and wait for it to finish
run = client.actor("tacps126/fda-device-clearances").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 '{
  "types": [
    "510k",
    "pma"
  ]
}' |
apify call tacps126/fda-device-clearances --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,tacps126/fda-device-clearances"
        }
    }
}
```

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/NLcQYxbR8qgiPFdVw/builds/lMfo46gykTrhHuu5O/openapi.json