# FDA 510(k) Device Clearances (`nexgenwatch/fda-510k-device-clearances`) Actor

Clean, structured records of medical-device 510(k) clearances, sourced live from the

- **URL**: https://apify.com/nexgenwatch/fda-510k-device-clearances.md
- **Developed by:** [NexGen Watch](https://apify.com/nexgenwatch) (community)
- **Categories:** News, Business
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $33.50 / 1,000 device clearances

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/platform/actors/running/actors-in-store#pay-per-event

## What's an Apify Actor?

Actors are web data automations that power AI and operations. They run on the Apify platform to scrape websites, process data, connect APIs, and automate workflows.
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.
Actors are written with capital "A".

## 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.
The best way to integrate Actors is as follows.

- **AI agents and MCP clients** — the [Apify MCP server](https://docs.apify.com/integrations/mcp.md) at `https://mcp.apify.com` (remote, streamable HTTP, OAuth on first use).
- **Agentic workflows and local Actor development** — [Agent Skills](https://apify.com/.well-known/agent-skills/index.json) with the [Apify CLI](https://docs.apify.com/cli/docs.md): `npm install -g apify-cli`, then `apify login`.
- **JavaScript/TypeScript projects** — the official [JS/TS client](https://docs.apify.com/api/client/js/docs.md): `npm install apify-client`.
- **Python projects** — the official [Python client](https://docs.apify.com/api/client/python/docs.md): `pip install apify-client`.
- **Any other language** — the [REST API](https://docs.apify.com/api/v2.md).

For usage examples, see the [API](#api) section below.

For more details, see Apify documentation as [Markdown index](https://docs.apify.com/llms.txt) and [Markdown full-text](https://docs.apify.com/llms-full.txt).

# README

## FDA 510(k) Device Clearances

Clean, structured records of medical-device 510(k) clearances, sourced live from the
official **openFDA device 510(k) API** (`https://api.fda.gov/device/510k.json`) — an
anonymous, documented U.S. Food & Drug Administration endpoint. One record per cleared
device (K-number), deduplicated, with the FDA's own fields carried exactly as published.

### What you get

One record per unique 510(k) clearance:

- `k_number` — the FDA clearance number (e.g. K123456)
- `applicant` — the submitting company
- `device_name` — the cleared device
- `product_code` — the FDA three-letter product code
- `decision_date` — clearance decision date (ISO `YYYY-MM-DD`)
- `decision_type` / `decision_code` — the FDA decision description and code
- `clearance_type` — e.g. Traditional, Special, Abbreviated
- `advisory_committee` — the FDA review panel
- `applicant_location` — city, state, country as filed
- `date_received` — submission received date
- `predicate_k_number` — always `null`: the openFDA 510(k) dataset does not publish
  predicate device numbers, so this is carried as an honest absence, never inferred
- `source`, `source_url`, `observed_at`

### Filtering

Bound your run by `applicant`, `productCode`, and a `decisionDateFrom`/`decisionDateTo`
window. `maxRecords` caps the number of records delivered (a buyer-requested bound on the
count, never a block). A filtered query that genuinely matches nothing succeeds and bills
nothing.

### How it behaves

The actor paginates the openFDA API newest-first, honouring the rate limit (~240
requests/minute) with a self-throttle. A source outage or a change in the API's response
shape stops the run loudly and charges nothing — an empty result is never delivered as a
success. A valid filtered query with no matches is a genuine empty result: it succeeds and
bills nothing.

### Data notes

This data comes directly from openFDA. Per the FDA's own disclaimer, do not rely on
openFDA to make decisions regarding medical care; fields are carried as published and are
not independently verified. This actor reports only what the FDA publishes.

### Pricing

| Event | FREE | BRONZE | SILVER | GOLD+ |
|---|---|---|---|---|
| `apify-actor-start` (one-time actor start) | $0.02 | $0.02 | $0.02 | $0.02 |
| `device_clearance` (per unique cleared device delivered) | $0.05 | $0.045 | $0.04 | $0.0335 |

You are charged once per unique clearance delivered (deduplicated on K-number). The
one-time start fee is $0.02. Duplicate K-numbers, filtered-out records, and genuine-empty
results are never billed; an outage or shape change charges nothing.

# Actor input Schema

## `applicant` (type: `array`):

Only deliver clearances whose applicant (submitter company) matches one of these names, e.g. Medtronic.

## `productCode` (type: `array`):

Restrict to these FDA product codes (three-letter codes, e.g. NHA, DXN).

## `decisionDateFrom` (type: `string`):

Only clearances decided on or after this date (YYYY-MM-DD).

## `decisionDateTo` (type: `string`):

Only clearances decided on or before this date (YYYY-MM-DD).

## `maxRecords` (type: `integer`):

Upper bound on clearance records delivered this run (a buyer-requested cap). Leave empty for the built-in ceiling.

## `maxPages` (type: `integer`):

Safety ceiling on API pages read.

## `pageLimit` (type: `integer`):

Records requested per openFDA page (max 1000; default 100).

## `minRequestIntervalSec` (type: `integer`):

Self-throttle between API pages to honour openFDA's rate limit (~240/min). Default under 1 second.

## `userAgent` (type: `string`):

Optional override for the identified contact User-Agent.

## Actor input object example

```json
{
  "applicant": [],
  "productCode": [],
  "maxRecords": 1000,
  "pageLimit": 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 = {};

// Run the Actor and wait for it to finish
const run = await client.actor("nexgenwatch/fda-510k-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 = {}

# Run the Actor and wait for it to finish
run = client.actor("nexgenwatch/fda-510k-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 '{}' |
apify call nexgenwatch/fda-510k-device-clearances --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,nexgenwatch/fda-510k-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/pAaAL7VutWPmCvcVZ/builds/BUADFyecAJ0YEvJdV/openapi.json