# Medical Device Clearances & Registrations (510(k), PMA) (`lepidata/medical-device-clearances`) Actor

US medical device 510(k) clearances, PMA approvals, establishment registrations and product codes from US government public data. Business fields only. Unofficial.

- **URL**: https://apify.com/lepidata/medical-device-clearances.md
- **Developed by:** [Lepi Data](https://apify.com/lepidata) (community)
- **Categories:** Business, Developer tools
- **Security:** Limited permissions
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $0.10 / 1,000 device records

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

**Not medical or regulatory advice; check the device's listing on the FDA database before relying on it.**

## Medical Device Clearances & Registrations (510(k), PMA)

US medical device 510(k) clearances, PMA approvals, establishment registrations and product codes from US government public data. Business fields only. Unofficial.

**Modes** (`endpoint`)

- `clearances`: 510(k) clearances; pages automatically up to Max results
- `clearance-detail`: 510(k) by K number (ids: K numbers, e.g. K243456)
- `approvals`: PMA approvals; pages automatically up to Max results
- `approval-detail`: PMA by number (ids: PMA numbers, e.g. P200001)
- `registrations`: Establishment registrations; pages automatically up to Max results
- `registration-detail`: Registration by number (ids: registration numbers)
- `product-codes`: Product codes

**Filters** are passed as JSON in `filters`, using the same names as the output's `query` object (e.g. {"q":"catheter"}).

**Output.** One row per record (`type: "record"`), plus `source_notice` and `removal` on every row. Free status rows (never charged): `invalid-input`, `not-found`, `no-results`, `api-error`, `service-busy`, `run-limit-reached`, `free-plan-limit`, `charge-limit-reached`.

Example row:

```json
{
 "k_number": "K262913",
 "decision_date": "2026-09-17",
 "date_received": "2026-08-19",
 "decision_code": "SESE",
 "decision": "Substantially Equivalent",
 "clearance_type": "Special",
 "device_name": "Stents, Drains And Dilators For The Biliary Ducts",
 "product_code": "FGE",
 "applicant": "Medtronic, Inc.",
 "city": "Plymouth",
 "state": "MN",
 "zip": "55441",
 "country_code": "US",
 "advisory_committee": "Gastroenterology, Urology",
 "statement_or_summary": "Summary",
 "third_party_review": false,
 "expedited_review": false,
 "device_class": "2",
 "regulation_number": "876.5010",
 "medical_specialty": "Gastroenterology, Urology",
 "device_name_classification": "Stents, Drains And Dilators For The Biliary Ducts",
 "document_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262913"
}
```

**Data source, notices and limits**

- US government public data: medical device premarket clearances (510(k), De Novo) and approvals (PMA), establishment registrations and device listings, and device classification, from the U.S. Food and Drug Administration (the source publishes it under CC0 1.0).
- Data provided by the U.S. Food and Drug Administration (https://open.fda.gov).
- Unofficial. Not affiliated with, endorsed by, or sponsored by the U.S. Food and Drug Administration or any government agency.
- Live from the public source (updated weekly or monthly), cached up to 24 hours; retrieved_at shows when, source_last_updated shows the source date.
- Company-level data. No contact persons, US agent persons, official correspondents, phone numbers, faxes or emails. Applicant street lines and ZIP+4 omitted (5-digit ZIP kept); registered establishment address kept.
- Removal requests: support@lepidata.com (handled within 30 days).
- Unofficial data provided as is. Not medical, legal or regulatory advice. A clearance or registration is not an endorsement of a device. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
- Records listed for removal on request are filtered out of every run.
- Source capacity is shared by all users of this tool. When it runs low or the source rate limits, runs stop cleanly with a free `service-busy` row. Hard cap: 500 source calls per run, paced (about one call every 0.5 s).
- Free-plan accounts get up to 100 results per run.

**Pricing.** Pay per result row, flat on every plan, no start fee. Status rows are free.

Contact: support@lepidata.com

# Actor input Schema

## `endpoint` (type: `string`):

Which data to fetch.

## `ids` (type: `array`):

For modes that need an ID: clearance-detail: K numbers, e.g. K243456; approval-detail: PMA numbers, e.g. P200001; registration-detail: registration numbers. Up to 200 per run.

## `filters` (type: `object`):

Query filters for the chosen mode, as JSON (see the README for each mode's filters). Unknown filters return a free invalid-input row.

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

Stop after this many paid result rows.

## Actor input object example

```json
{
  "endpoint": "clearances",
  "filters": {
    "q": "catheter"
  },
  "maxItems": 20
}
```

# Actor output Schema

## `items` (type: `string`):

All rows from this run.

# 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 = {
    "endpoint": "clearances",
    "filters": {
        "q": "catheter"
    },
    "maxItems": 20
};

// Run the Actor and wait for it to finish
const run = await client.actor("lepidata/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 = {
    "endpoint": "clearances",
    "filters": { "q": "catheter" },
    "maxItems": 20,
}

# Run the Actor and wait for it to finish
run = client.actor("lepidata/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 '{
  "endpoint": "clearances",
  "filters": {
    "q": "catheter"
  },
  "maxItems": 20
}' |
apify call lepidata/medical-device-clearances --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,lepidata/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/lQPjNUv8FFLDWrF76/builds/ge4g58v8eXawjQtmZ/openapi.json