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

Every FDA medical device 510(k) clearance and PMA approval or supplement from openFDA. Filter by company, product code, device name, review panel and decision date. Decision and receipt dates on every row.

- **URL**: https://apify.com/pushbuild/fda-device-clearances.md
- **Developed by:** [Pushbuild Data](https://apify.com/pushbuild) (community)
- **Categories:** Business, Other
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

$0.30 / 1,000 decisions

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 Device 510(k) Clearances & PMA Approvals

Every FDA medical device 510(k) clearance and PMA decision, from openFDA, in clean JSON.

### What you get

Type (510k or PMA), K or P number, supplement, company, device and generic name, product code, device class, regulation number, medical specialty and review panel, **date received and decision date**, decision, clearance type, expedited and third-party review flags, location, and a link to the FDA record.

### Use cases

- Track clearances and approvals for medtech companies you follow.
- Competitive intelligence by product code (for example every radiology triage software clearance).
- Event studies: decision dates for original PMAs.

### Input examples

```json
{"applicant": "Medtronic", "dateFrom": "2026-01-01"}
```

```json
{"dataset": "pma", "originalPmaOnly": true, "dateFrom": "2025-01-01"}
```

```json
{"dataset": "510k", "productCodes": ["QAS", "QIH"], "dateFrom": "2024-01-01"}
```

### Notes

- openFDA refreshes device data weekly.
- Pricing: per decision returned.

# Actor input Schema

## `dataset` (type: `string`):

Which decisions to return.

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

e.g. Medtronic, Boston Scientific.

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

Matches the device, trade or generic name.

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

Three-letter product codes, e.g. QAS (radiology triage software).

## `advisoryCommittee` (type: `string`):

Two-letter code, e.g. CV (cardiovascular), RA (radiology), OR (orthopedic).

## `decisionCode` (type: `string`):

e.g. SESE (substantially equivalent). 510(k) only.

## `originalPmaOnly` (type: `boolean`):

Skip PMA supplements and 30-day notices.

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

YYYY-MM-DD. Default: 30 days ago.

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

YYYY-MM-DD. Default: today.

## `sort` (type: `string`):

By decision date.

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

Maximum rows returned.

## Actor input object example

```json
{
  "dataset": "both",
  "applicant": "Medtronic",
  "originalPmaOnly": false,
  "sort": "newest",
  "maxItems": 1000
}
```

# 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 = {
    "applicant": "Medtronic"
};

// Run the Actor and wait for it to finish
const run = await client.actor("pushbuild/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 = { "applicant": "Medtronic" }

# Run the Actor and wait for it to finish
run = client.actor("pushbuild/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 '{
  "applicant": "Medtronic"
}' |
apify call pushbuild/fda-device-clearances --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,pushbuild/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/fRnfJcUEgUJhBDc6W/builds/mce1ldq3dqn0NcES4/openapi.json