# US Medical Device Clearances — 510(k) & PMA Decisions (`plaindata/us-medical-device-clearances`) Actor

Track US medical device 510(k) clearances and PMA approvals by date, device keyword, product code or applicant: decision, device class, specialty, links. Data: openFDA device API (CC0), not affiliated.

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

## Pricing

from $1.50 / 1,000 result returneds

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

## US Medical Device Clearances — 510(k) & PMA Decisions

Track **US medical device market authorisations**: 510(k) clearances and PMA approvals (including supplements) via the official **openFDA device API**. Filter by decision date, device keyword, product code or applicant company — ideal for competitive intelligence, regulatory monitoring, medtech sales and investor research.

### Input examples

```json
{ "pathway": "both", "lastDays": 30, "maxItems": 100 }
{ "pathway": "510k", "searchText": "catheter", "lastDays": 90 }
{ "applicant": "Medtronic", "decidedFrom": "2026-01-01", "maxItems": 500 }
{ "productCodes": ["DQY", "LWP"], "lastDays": 365 }
```

### Output (one row per decision)

| Field | Meaning |
|---|---|
| pathway | 510(k) or PMA |
| decisionNumber, supplementNumber | K-number or PMA number (+ supplement) |
| deviceName, tradeName | Device name; trade name for PMA |
| applicant, city, state, country | Submitting company and location (no street address) |
| productCode, deviceClass, regulationNumber, medicalSpecialty | Classification |
| dateReceived, decisionDate, decisionCode, decision | Timeline and outcome (510(k) decision text or PMA approval-order statement) |
| submissionType, reason | 510(k) clearance type / PMA supplement type and reason |
| statementOrSummary, thirdPartyReview, expeditedReview | Review details |
| fdaUrl | Link to the official database entry |
| source | Data source statement |

### Data source & licence

openFDA device 510(k) and PMA endpoints. openFDA data is dedicated to the public domain under CC0: "You can copy, modify, distribute and perform the work, even for commercial purposes, all without asking permission." GMDN content is not used.

### Privacy

The 510(k) contact-person field and street addresses are never output. Any e-mail address or phone number inside text is masked.

### Notes

Do not rely on this data for medical decisions; openFDA results are unvalidated. Requests are spaced (about two per second). Not affiliated with or endorsed by the U.S. Food and Drug Administration.

# Actor input Schema

## `pathway` (type: `string`):

Which decisions to return.

## `searchText` (type: `string`):

Matches device name (510(k)) or generic/trade name (PMA), e.g. catheter, glucose, stent.

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

Three-letter device product codes, e.g. DQY, LWP, QAS.

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

Company name, e.g. Medtronic.

## `lastDays` (type: `integer`):

Used when 'Decided from' is empty.

## `decidedFrom` (type: `string`):

YYYY-MM-DD

## `decidedTo` (type: `string`):

YYYY-MM-DD

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

Up to 5,000 per run (per pathway when both).

## Actor input object example

```json
{
  "pathway": "both",
  "lastDays": 30,
  "maxItems": 100
}
```

# 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 = {
    "lastDays": 30,
    "maxItems": 100
};

// Run the Actor and wait for it to finish
const run = await client.actor("plaindata/us-medical-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 = {
    "lastDays": 30,
    "maxItems": 100,
}

# Run the Actor and wait for it to finish
run = client.actor("plaindata/us-medical-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 '{
  "lastDays": 30,
  "maxItems": 100
}' |
apify call plaindata/us-medical-device-clearances --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,plaindata/us-medical-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/0C8IAhPD8ucz5aVqj/builds/Hd8KLPvkgYCcOuduL/openapi.json