# 🩺 FDA 510(k) Clearance Competitive Intelligence (`snuggly_beanie_970/fda-510k-clearance-competitive-intelligence`) Actor

Find new FDA 510(k) clearances with applicant, product-code classification, review duration, regulatory flags, competitive activity counts and official evidence links.

- **URL**: https://apify.com/snuggly\_beanie\_970/fda-510k-clearance-competitive-intelligence.md
- **Developed by:** [Ilia](https://apify.com/snuggly_beanie_970) (community)
- **Categories:** Lead generation, Automation
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $3.00 / 1,000 enriched 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?

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) Clearance Competitive Intelligence

Find newly cleared medical devices and understand the competitive signal behind each FDA decision. This Actor combines the official openFDA 510(k) and device-classification datasets instead of returning thin clearance rows.

### Results include

- K number, device, applicant, decision/received dates, clearance pathway and calculated review duration;
- product code, medical specialty, regulatory class/number and the FDA classification definition;
- implant, life-support, GMP exemption, third-party eligibility/review and expedited-review flags;
- applicant and product-code clearance counts within the selected window;
- applicant address, contact, FEI and registration identifiers;
- direct FDA clearance page, downloadable 510(k) summary PDF and exact API evidence URL.

### Useful searches

```json
{
  "keywords": ["artificial intelligence", "software"],
  "decisionDateFrom": "2026-08-01",
  "decisionDateTo": "2026-08-31",
  "onlySubstantiallyEquivalent": true,
  "includeClassification": true,
  "maxItems": 100
}
```

Filter by applicant names to monitor competitors, or by FDA product codes to watch a device category. Schedule the Actor weekly to create a current regulatory and business-development feed.

### Source

Live data comes from the official openFDA 510(k) and device-classification APIs. Every record retains direct FDA source links for verification.

### 📥 Complete input reference

| Field | Type | Default | Purpose |
|---|---|---:|---|
| `keywords` | array | `[]` | Match any keyword across device name and applicant. |
| `applicants` | array | `[]` | Restrict results to named applicants or manufacturers. |
| `productCodes` | array | `[]` | Restrict results to three-letter FDA product codes. |
| `decisionDateFrom` | string | `"2026-08-01"` | Inclusive YYYY-MM-DD decision-date lower bound. |
| `decisionDateTo` | string | `"2026-08-31"` | Inclusive YYYY-MM-DD decision-date upper bound. |
| `clearanceTypes` | array | `[]` | Optional values such as Traditional, Special or Abbreviated. |
| `onlySubstantiallyEquivalent` | boolean | `true` | Keep only decisions whose FDA decision description is Substantially Equivalent. |
| `includeClassification` | boolean | `true` | Add regulatory class, definition and risk-relevant product-code flags. |
| `maxItems` | integer | `100` | Maximum matching clearance records to store. |

### 📤 Complete output reference

The default dataset is exportable as JSON, CSV, Excel, XML or RSS. Fields remain stable for scheduled runs and API integrations.

| Field | Type |
|---|---|
| `kNumber` | string |
| `deviceName` | string |
| `applicant` | string |
| `decisionDate` | string |
| `dateReceived` | string |
| `reviewDays` | integer / null |
| `decisionDescription` | string |
| `clearanceType` | string |
| `productCode` | string |
| `medicalSpecialty` | string / null |
| `deviceClass` | string / null |
| `classificationName` | string / null |
| `classificationDefinition` | string / null |
| `regulationNumber` | string / null |
| `implantFlag` | boolean / null |
| `lifeSustainSupportFlag` | boolean / null |
| `gmpExemptFlag` | boolean / null |
| `thirdPartyEligible` | boolean / null |
| `thirdPartyReviewed` | boolean |
| `expeditedReview` | boolean |
| `summaryAvailable` | boolean |
| `applicantClearancesInWindow` | integer |
| `productCodeClearancesInWindow` | integer |
| `applicantAddress` | string |
| `countryCode` | string |
| `contact` | string |
| `registrationNumbers` | array |
| `feiNumbers` | array |
| `official510kUrl` | string |
| `summaryPdfUrl` | string |
| `officialApiUrl` | string |
| `sourceLastUpdated` | string / null |
| `scrapedAt` | string |

### 🔌 API & integrations

Run this Actor from the Apify Console, API, CLI, MCP, Make, Zapier or n8n. Replace the Actor identifier and token in this template:

```bash
curl -X POST "https://api.apify.com/v2/acts/fda-510k-clearance-competitive-intelligence/runs?token=YOUR_TOKEN" \
  -H "Content-Type: application/json" \
  -d '{}'
```

Results are stored in the run's default dataset and can be forwarded with Apify webhooks or scheduled Tasks.

### 🔎 Search keywords

FDA 510(k) Clearance Competitive Intelligence, fda, 510, clearance, competitive, intelligence, 510k, Apify Actor, scraper API, structured data, scheduled monitor, automation.

### 💰 Pricing

Billing is tied to successfully delivered result events. Empty, filtered, duplicate or failed records are not charged as results. Open the **Pricing** tab for the current per-event rate before starting a run, and use Apify's maximum-charge control to enforce a hard budget.

# Actor input Schema

## `keywords` (type: `array`):

Match any keyword across device name and applicant.

## `applicants` (type: `array`):

Restrict results to named applicants or manufacturers.

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

Restrict results to three-letter FDA product codes.

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

Inclusive YYYY-MM-DD decision-date lower bound.

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

Inclusive YYYY-MM-DD decision-date upper bound.

## `clearanceTypes` (type: `array`):

Optional values such as Traditional, Special or Abbreviated.

## `onlySubstantiallyEquivalent` (type: `boolean`):

Keep only decisions whose FDA decision description is Substantially Equivalent.

## `includeClassification` (type: `boolean`):

Add regulatory class, definition and risk-relevant product-code flags.

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

Maximum matching clearance records to store.

## Actor input object example

```json
{
  "keywords": [],
  "applicants": [],
  "productCodes": [],
  "decisionDateFrom": "2026-08-01",
  "decisionDateTo": "2026-08-31",
  "clearanceTypes": [],
  "onlySubstantiallyEquivalent": true,
  "includeClassification": true,
  "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 = {};

// Run the Actor and wait for it to finish
const run = await client.actor("snuggly_beanie_970/fda-510k-clearance-competitive-intelligence").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("snuggly_beanie_970/fda-510k-clearance-competitive-intelligence").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 snuggly_beanie_970/fda-510k-clearance-competitive-intelligence --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,snuggly_beanie_970/fda-510k-clearance-competitive-intelligence"
        }
    }
}

```

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/OINFd56K9ZkutKqKX/builds/5WjRa2Ofc3nm8vzhO/openapi.json