# FDA 510(k) Device Clearances Lead Finder (`northlinestudio/fda-510k-clearances`) Actor

Find medical device manufacturers with recent FDA 510(k) clearances via the official openFDA API. Ideal for B2B lead gen, competitive intel, and clearance monitoring — no API key required.

- **URL**: https://apify.com/northlinestudio/fda-510k-clearances.md
- **Developed by:** [Northline Studio](https://apify.com/northlinestudio) (community)
- **Categories:** Lead generation
- **Security:** Limited permissions
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

Pay per usage

This Actor is paid per platform usage. The Actor is free to use, and you only pay for the Apify platform usage, which gets cheaper the higher subscription plan you have.

Learn more: https://docs.apify.com/actors/running/actors-in-store.md#pay-per-usage

## 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 Lead Finder

Find **medical device manufacturers** with recent U.S. FDA **510(k)** clearances from the official [openFDA](https://open.fda.gov/apis/device/510k/) API — company name, device, product code, decision date, and address fields when FDA publishes them. Built by **Northline Studio** for medtech sales, competitive intelligence, and clearance monitoring without building a custom openFDA client.

Data comes **only** from `api.fda.gov` (public official FDA data; no scraping, no login, no API key required for typical volumes).

### Why this Actor

- **B2B lead gen** — Fresh manufacturers that just cleared a device through the 510(k) pathway.
- **Official source** — Same openFDA device/510k endpoint FDA documents for public use.
- **Cheap & fast defaults** — Default 60-day lookback / 25 results finishes well under a minute.
- **Monitor-friendly** — Optional cross-run dedupe so scheduled runs emit only new K-numbers.
- **Flat JSON** — One clean record per clearance for CRM / spreadsheet workflows.

### Features

- Filter by lookback window or absolute decision-date range
- Optional applicant name, device name, product code, and decision-code filters
- Sorted by newest decision date first
- Practice-ready address fields when present on the record
- Declared User-Agent and polite rate limiting

### Input

| Field | Type | Default | Description |
| --- | --- | --- | --- |
| `lookbackDays` | integer | `60` | Decision dates on/after today − lookback + 1 |
| `sinceDate` / `untilDate` | string | *(empty)* | Optional absolute YYYY-MM-DD bounds |
| `applicantContains` | string | *(empty)* | Filter on manufacturer / applicant name |
| `deviceNameContains` | string | *(empty)* | Filter on device name |
| `productCode` | string | *(empty)* | FDA product code (e.g. `GCJ`) |
| `decisionCodes` | string\[] | `[]` | Optional codes such as `SESE` |
| `maxResults` | integer | `25` | Cap on records (max 1,000) |
| `dedupeAcrossRuns` | boolean | `false` | Skip K-numbers seen in prior runs |
| `userAgent` | string | `Northline Studio northlinestd@proton.me` | HTTP User-Agent |
| `maxRequestsPerSecond` | number | `2` | openFDA rate limit |

#### Example input — last 60 days (default-style)

```json
{
  "lookbackDays": 60,
  "maxResults": 25,
  "dedupeAcrossRuns": false
}
```

#### Example input — orthopedic product code

```json
{
  "lookbackDays": 180,
  "productCode": "HRS",
  "maxResults": 100
}
```

### Output

Each dataset item is one 510(k) clearance. Key fields:

| Field | Description |
| --- | --- |
| `kNumber` | FDA 510(k) number |
| `applicant` | Manufacturer / applicant name |
| `deviceName` | Cleared device name |
| `productCode` | FDA product code |
| `decisionDate` | Decision date (YYYY-MM-DD) |
| `decisionCode` | Decision code (e.g. SESE) |
| `city` / `state` / `postalCode` | Applicant address when present |
| `openfdaMedicalSpecialty` | Specialty from the openfda block |
| `fdaUrl` | Link to the clearance on accessdata.fda.gov |
| `source` | `api.fda.gov` |

#### Example output item

```json
{
  "kNumber": "K241234",
  "applicant": "EXAMPLE MEDTECH INC",
  "deviceName": "Example Orthopedic Implant",
  "productCode": "HRS",
  "decisionDate": "2025-09-15",
  "decisionCode": "SESE",
  "state": "CA",
  "fdaUrl": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241234",
  "source": "api.fda.gov"
}
```

### Pricing

**Free** for now. Paid per-result pricing may be added later — check the Store pricing panel for the live rate.

### Use cases

- Medtech sales teams prospecting manufacturers with brand-new clearances
- Competitive intelligence on who cleared what in a product-code niche
- Agencies building contact lists for device makers entering a specialty
- Scheduled monitors for new clearances (enable `dedupeAcrossRuns`)

### Notes & limits

- Anonymous openFDA access is rate-limited (about 240 requests/minute, 1,000/day without a key). This Actor defaults to 2 req/s.
- openFDA returns HTTP 404 when a search matches zero documents — treated as an empty result set, not a hard failure.
- Address fields are only as complete as FDA publishes them on each record.
- A clearance does **not** by itself prove commercial availability or marketing authorization beyond what FDA publishes for that K-number.

### Source

- API docs: https://open.fda.gov/apis/device/510k/
- Endpoint: `https://api.fda.gov/device/510k.json`
- Public official data from the U.S. Food and Drug Administration (openFDA)

Built by **Northline Studio**.

# Actor input Schema

## `lookbackDays` (type: `integer`):

Include clearances with decision_date on/after (today − lookbackDays + 1). Ignored when sinceDate is set. Default 60 keeps the daily auto-test reliable.

## `sinceDate` (type: `string`):

Optional absolute start date for decision_date. When set, overrides lookbackDays.

## `untilDate` (type: `string`):

Optional end date for decision_date (defaults to today).

## `applicantContains` (type: `string`):

Optional filter on the manufacturer / applicant name (openFDA full-text on applicant).

## `deviceNameContains` (type: `string`):

Optional filter on device_name.

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

Optional FDA product code (e.g. GCJ). Leave empty for all codes.

## `decisionCodes` (type: `array`):

Optional decision code filters (e.g. SESE = Substantially Equivalent). Leave empty for all decisions in the date window.

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

Maximum clearance records to return. Default 25 keeps runs cheap and under one minute.

## `dedupeAcrossRuns` (type: `boolean`):

Skip K-numbers already seen in previous runs. Leave off for one-off lead pulls and Store quality checks.

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

HTTP User-Agent sent to api.fda.gov.

## `maxRequestsPerSecond` (type: `number`):

Polite rate limit for openFDA. Default 2 req/s (well under the anonymous 240/min cap).

## Actor input object example

```json
{
  "lookbackDays": 60,
  "sinceDate": "",
  "untilDate": "",
  "applicantContains": "",
  "deviceNameContains": "",
  "productCode": "",
  "decisionCodes": [],
  "maxResults": 25,
  "dedupeAcrossRuns": false,
  "userAgent": "Northline Studio northlinestd@proton.me",
  "maxRequestsPerSecond": 2
}
```

# Actor output Schema

## `overview` (type: `string`):

All clearance results with key lead fields.

# 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 = {
    "lookbackDays": 60,
    "sinceDate": "",
    "untilDate": "",
    "applicantContains": "",
    "deviceNameContains": "",
    "productCode": "",
    "decisionCodes": [],
    "maxResults": 25,
    "dedupeAcrossRuns": false,
    "userAgent": "Northline Studio northlinestd@proton.me",
    "maxRequestsPerSecond": 2
};

// Run the Actor and wait for it to finish
const run = await client.actor("northlinestudio/fda-510k-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 = {
    "lookbackDays": 60,
    "sinceDate": "",
    "untilDate": "",
    "applicantContains": "",
    "deviceNameContains": "",
    "productCode": "",
    "decisionCodes": [],
    "maxResults": 25,
    "dedupeAcrossRuns": False,
    "userAgent": "Northline Studio northlinestd@proton.me",
    "maxRequestsPerSecond": 2,
}

# Run the Actor and wait for it to finish
run = client.actor("northlinestudio/fda-510k-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 '{
  "lookbackDays": 60,
  "sinceDate": "",
  "untilDate": "",
  "applicantContains": "",
  "deviceNameContains": "",
  "productCode": "",
  "decisionCodes": [],
  "maxResults": 25,
  "dedupeAcrossRuns": false,
  "userAgent": "Northline Studio northlinestd@proton.me",
  "maxRequestsPerSecond": 2
}' |
apify call northlinestudio/fda-510k-clearances --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,northlinestudio/fda-510k-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/PRPqIaiUmCBHJoEt5/builds/TkDiZPKDuM1gTkrWA/openapi.json