# FDA 510(k) Device Clearances Search — Fast API (`quartz_apple_dnx/fda-510k-clearances-search-api`) Actor

Search public FDA 510(k) device clearance records through openFDA by applicant, device name, product code, committee, K number, or decision date.

- **URL**: https://apify.com/quartz_apple_dnx/fda-510k-clearances-search-api.md
- **Developed by:** [Piven Core](https://apify.com/quartz_apple_dnx) (community)
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

$0.25 / 1,000 fda 510(k) clearances

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 510(k) Device Clearances Search — Fast API

Search FDA 510(k) device-clearance records through the public openFDA API and export structured clearance rows.

Use it for **medical-device regulatory research, competitor research, product-code analysis, clearance monitoring, device-market research, and automated FDA-data workflows**.

### Common use cases

- Search 510(k) clearances by applicant or device name
- Research devices by FDA product code or advisory committee
- Look up an exact K number
- Filter clearances by decision-date range
- Build structured clearance datasets for regulatory or market research

### What you get

Each billable row represents one 510(k) clearance and can include K number, applicant, device name, product code, committee, clearance type, decision code/description/date, received date, third-party/expedited flags, applicant location, openFDA annotations and exact source provenance.

### Source

`https://api.fda.gov/device/510k.json`

openFDA documents that an API key is not required for normal public use. The 510(k) endpoint currently permits up to **1,000 records in a single request**.

### Input

Search by applicant, device name, FDA product code, advisory committee, exact K number, or decision-date range. Leave filters blank to browse the source-default clearance list.

The Store default saves at most 25 rows.

### Important limitations

V1 deliberately does not join the separate FDA Device Classification endpoint and does not fetch decision summaries or other documents.

A 510(k) clearance record should not be interpreted as a medical recommendation, a guarantee of device safety or effectiveness, or evidence that two devices are clinically equivalent for a particular use. This Actor reports source records; important regulatory conclusions require review of the applicable FDA materials.

### Pricing

Only successfully saved clearance rows are billed. Exact openFDA “No matches found” responses become one non-billed summary row; other source failures remain failures.

Private candidate target: **$0.25 per 1,000 clearance rows**, subject to live economics and a final Store-price recheck.

Public release is a separate decision.

### About Piven Core

Built and maintained by **Piven Core** — focused data APIs and automation utilities for reliable, production-ready workflows.

Learn more: https://pivencore.com

# Actor input Schema

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

Optional case-insensitive applicant/company contains search.

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

Optional case-insensitive device-name contains search.

## `productCode` (type: `string`):

Optional FDA product code, such as DQY.

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

Optional committee code, such as CV.

## `kNumber` (type: `string`):

Optional exact 510(k) K number.

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

Optional earliest FDA decision date in YYYY-MM-DD format.

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

Optional latest FDA decision date in YYYY-MM-DD format.

## `maxRows` (type: `integer`):

Hard cap on saved billable clearance rows.

## Actor input object example

```json
{
  "maxRows": 25
}
```

# Actor output Schema

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

No description

## `summary` (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 = {
    "maxRows": 25
};

// Run the Actor and wait for it to finish
const run = await client.actor("quartz_apple_dnx/fda-510k-clearances-search-api").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 = { "maxRows": 25 }

# Run the Actor and wait for it to finish
run = client.actor("quartz_apple_dnx/fda-510k-clearances-search-api").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 '{
  "maxRows": 25
}' |
apify call quartz_apple_dnx/fda-510k-clearances-search-api --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,quartz_apple_dnx/fda-510k-clearances-search-api"
        }
    }
}
```

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/6fJ1vrL3BpNQFjwBk/builds/WanXJQDvCoBsrKVfy/openapi.json