# FDA 510(k) Clearance Search: Medical Device Premarket (`smilemask/fda-510k-device-clearance-search`) Actor

Search US FDA 510(k) premarket notification decisions by device name, applicant company, product code, K number or medical specialty. Returns K number, device, applicant, decision, decision and received dates, device class, regulation, clearance type and city, newest first. Free CC0 openFDA data.

- **URL**: https://apify.com/smilemask/fda-510k-device-clearance-search.md
- **Developed by:** [돈벼락](https://apify.com/smilemask) (community)
- **Categories:** Developer tools
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $2.00 / 1,000 results

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) Clearance Search: Medical Device Premarket

Search US FDA 510(k) premarket notification decisions by device name, applicant company, product code, K number or medical specialty. Returns K number, device, applicant, decision, decision and received dates, device class, regulation, clearance type and city, newest first. Free CC0 openFDA data.

### What does FDA 510(k) Clearance Search do?

Search US FDA 510(k) medical device clearances by device, company, product code or specialty, newest decisions first.

### What can you use it for?

- Track new FDA clearances from competitors such as Medtronic, Abbott or Dexcom.
- Find predicate devices for a new 510(k) submission by product code or device name.
- Monitor clearance activity in a specialty (cardiovascular, radiology, orthopedic) for market research.
- Build sales lead lists of device makers that just cleared a product.

### Why use this Actor?

- **Fast and cheap:** lightweight HTTP-based Actor with no browser, so runs finish in seconds and cost very little.
- **No API keys or accounts needed** for the data source (see notes below).
- **Clean, structured JSON** that you can export as CSV, Excel, JSON or XML, or pull through the Apify API and integrations.
- **Scheduling, webhooks and integrations:** run it daily and send results to Google Sheets, Slack, Zapier, Make, n8n or your own API.

### Input

Configure the run in the **Input** tab (all fields have sensible defaults).

| Field | Type | Required | Default | Description |
|---|---|---|---|---|
| `query` | string | yes | - | e.g. insulin pump, stent, a company name, a 3-letter product code (QFG) or a K number. |
| `searchField` | string (device_name / applicant / product_code / k_number / openfda.device_name / advisory_committee_description) | no | `"device_name"` | Which 510(k) field to match. |
| `decidedAfter` | string | no | - | Optional. Only return decisions on or after this date, e.g. 2025-01-01. |
| `maxResults` | integer | no | `50` | Maximum number of 510(k) decisions. |
| `apiKey` | string | no | - | Free key from open.fda.gov raises the rate limit. Stored encrypted. |

#### Example input

```json
{
  "query": "insulin pump",
  "maxResults": 20
}
```

### Output

Results are stored in the default dataset. Download them from the **Output** tab or via the API.

#### Example result

```json
{
  "kNumber": "K253470",
  "deviceName": "MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)",
  "applicant": "Medtronic Minimed, Inc.",
  "decision": "Substantially Equivalent",
  "decisionCode": "SESE",
  "decisionDate": "2026-01-15",
  "dateReceived": "2025-10-10",
  "clearanceType": "Traditional",
  "productCode": "QFG",
  "deviceType": "Alternate Controller Enabled Insulin Infusion Pump",
  "deviceClass": "2",
  "regulationNumber": "880.5730",
  "specialty": "Clinical Chemistry",
  "summaryOrStatement": "Summary",
  "thirdPartyReview": "N",
  "contact": "Amber Street",
  "city": "Northridge",
  "state": "CA",
  "country": "US",
  "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253470",
  "scrapedAt": "2026-10-22T20:38:41.706Z"
}
```

#### Output fields

| Field | Type | Example |
|---|---|---|
| `kNumber` | string | "K253470" |
| `deviceName` | string | "MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insul... |
| `applicant` | string | "Medtronic Minimed, Inc." |
| `decision` | string | "Substantially Equivalent" |
| `decisionCode` | string | "SESE" |
| `decisionDate` | string | "2026-01-15" |
| `dateReceived` | string | "2025-10-10" |
| `clearanceType` | string | "Traditional" |
| `productCode` | string | "QFG" |
| `deviceType` | string | "Alternate Controller Enabled Insulin Infusion Pump" |
| `deviceClass` | string | "2" |
| `regulationNumber` | string | "880.5730" |
| `specialty` | string | "Clinical Chemistry" |
| `summaryOrStatement` | string | "Summary" |
| `thirdPartyReview` | string | "N" |
| `contact` | string | "Amber Street" |
| `city` | string | "Northridge" |
| `state` | string | "CA" |
| `country` | string | "US" |
| `url` | string | "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn... |
| `scrapedAt` | string | "2026-10-22T20:38:41.706Z" |

### How much does it cost?

The Actor is billed by Apify according to the pricing shown on the **Pricing** tab of this page. Runs are small and fast, and the Apify Free plan includes monthly platform credits so you can try it at no cost. You can set a maximum cost per run, and the Actor stops cleanly when that limit is reached.

### Notes and limitations

- Source: openFDA device 510(k) endpoint (US FDA), newest decision first.
- Device class 3 is the highest-risk category. Informational only, not regulatory or medical advice.

### Tips

- Start with a small test run, then scale up the input.
- Use **Schedules** to automate recurring runs and **Webhooks** or **Integrations** to deliver the data where you need it.
- Call the Actor from your code with the Apify API or the official JavaScript and Python clients.

### FAQ

**Can I use my own openFDA key?**

Yes, paste it in the optional API key field for higher rate limits.

**How fresh is the data?**

openFDA updates 510(k) decisions weekly.

**What is a K number?**

The FDA ID of a 510(k) submission, e.g. K253470. The url field opens its official FDA page.

### Feedback

Found a bug or need an extra field? Open an issue from the **Issues** tab of this Actor and it will be looked at quickly.

### More tools from the same author

- [Medical Device Recalls: FDA Device Recall Search](https://apify.com/SmileMask/fda-medical-device-recalls) - Search official US FDA medical device recalls by product, reason, firm or device type with root cause and dates.
- [NDC Drug Directory: FDA National Drug Code Lookup & Search](https://apify.com/SmileMask/fda-ndc-drug-directory-search) - Search the official FDA National Drug Code (NDC) Directory by NDC, brand, generic name, ingredient, labeler or drug class.
- [Clinical Trials Search: ClinicalTrials.gov Studies & Sponsors](https://apify.com/SmileMask/clinical-trials-search) - Search ClinicalTrials.gov by condition, drug and status: phases, sponsors, enrollment, dates and countries.

# Changelog

This Actor's version history is a separate document: https://apify.com/smilemask/fda-510k-device-clearance-search/changelog.md

# Actor input Schema

## `query` (type: `string`):

e.g. insulin pump, stent, a company name, a 3-letter product code (QFG) or a K number.

## `searchField` (type: `string`):

Which 510(k) field to match.

## `decidedAfter` (type: `string`):

Optional. Only return decisions on or after this date, e.g. 2025-01-01.

## `maxResults` (type: `integer`):

Maximum number of 510(k) decisions.

## `apiKey` (type: `string`):

Free key from open.fda.gov raises the rate limit. Stored encrypted.

## Actor input object example

```json
{
  "query": "insulin pump",
  "searchField": "device_name",
  "maxResults": 20
}
```

# 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 = {
    "query": "insulin pump",
    "maxResults": 20
};

// Run the Actor and wait for it to finish
const run = await client.actor("smilemask/fda-510k-device-clearance-search").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 = {
    "query": "insulin pump",
    "maxResults": 20,
}

# Run the Actor and wait for it to finish
run = client.actor("smilemask/fda-510k-device-clearance-search").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 '{
  "query": "insulin pump",
  "maxResults": 20
}' |
apify call smilemask/fda-510k-device-clearance-search --silent --output-dataset

```

## MCP server setup

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

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/cHUxfbG7mDuEFy09H/builds/pmCrcISdR9rb8Vufz/openapi.json