# FDA 510(k) Clearances Scraper — Device Approvals (`devilscrapes/fda-510k-clearances-scraper`) Actor

Export openFDA 510(k) premarket device clearance records — applicant, device name, decision date and code, product code, advisory committee, device class and regulation number — filterable by applicant, device, product code, committee, class or decision-date range, as clean JSON, CSV or Excel.

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

## Pricing

Pay per event

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/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

<div align="center">
  <img src=".actor/icon.svg" width="160" alt="Devil Scrapes mark" />

## FDA 510(k) Clearances Scraper — Device Approvals

**💰 $2.05 / 1 000 results**  ·  pay only for results  ·  no credit card to try

*We do the dirty work so your dataset stays clean.* 😈

Export openFDA 510(k) premarket device clearance records — applicant, device name, decision date and code, product code, advisory committee, device class and regulation number — filterable by applicant, device, product code, committee, class or decision-date range, as clean JSON, CSV or Excel.

</div>

***

### 🎯 What this scrapes

openFDA publishes every 510(k) premarket clearance the agency has granted — the fastest public record of which device just got cleared to market and who cleared it. The raw API hides a 25 000-record pagination ceiling, an intermittent cold-query 500, and a sparse `openfda` enrichment block that breaks naive parsers the first time a record ships without it. This Actor normalises all of that into one dependable row shape, so a market-entry or competitive-intelligence watchlist becomes a spreadsheet instead of a scripting project.

### 🔥 What we handle for you

- 🛡️ **Browser fingerprint rotation** — `curl-cffi` impersonates real Chrome / Firefox / Safari TLS handshakes on every request.
- 🔁 **Retries with exponential backoff** on `408 / 429 / 5xx`, including openFDA's documented cold-query timeouts — up to 5 attempts per page.
- 🧱 **Stops cleanly at openFDA's pagination ceiling** instead of looping on a 400, and fails loud (not silently empty) if the endpoint goes down for 3 consecutive pages.
- 🧊 **Per-record fault isolation** — one malformed record never takes down the run; we skip it, log it, and keep paging.
- 🧊 **Clean, typed dataset rows** — Pydantic-validated, stable `k_number` identifiers, JSON / CSV / Excel export straight from the Apify Console.
- 💰 **Pay-Per-Event pricing** — you only pay for results that hit your dataset. No data, no charge.

### 💡 Use cases

- Track which devices a competitor just cleared to market, and how fast their submissions move through FDA review.
- Build a market-entry brief on every 510(k) clearance for a product code before entering that device category.
- Feed a due-diligence or investment model with clearance velocity by applicant, advisory committee or device class.
- Monitor a specific device class or committee for new clearances on a recurring schedule.

### ⚙️ How to use it

1. Click **Try for free** at the top of the page.
2. Fill in the input form — most fields have sensible defaults.
3. Click **Start**. Output streams into the run's dataset.
4. Export from **Storage → Dataset** as JSON, CSV, or Excel — or fetch via the API.

### 📥 Input

| Field | Type | Required | Default | Notes |
|---|---|:--:|---|---|
| `applicant` | `string` | no | 'Medtronic' | Filter: applicant/company name that filed the 510(k). Matches openFDA's <code>applicant</code> field. |
| `deviceName` | `string` | no | 'Cardiac Monitor' | Filter: device name. Matches openFDA's <code>device\_name</code> field. |
| `productCode` | `string` | no | 'DXH' | Filter: FDA product code. Matches openFDA's <code>product\_code</code> field. |
| `advisoryCommittee` | `string` | no | 'Cardiovascular' | Filter: advisory committee description. Matches openFDA's <code>advisory\_committee\_description</code> field. |
| `deviceClass` | `string` | no | '2' | Filter: FDA device class. Matches openFDA's <code>openfda.device\_class</code> field. |
| `decisionDateFrom` | `string` | no | '20240101' | Only include clearances decided on or after this date, as <code>YYYYMMDD</code>. Leave empty for no floor. |
| `decisionDateTo` | `string` | no | '20241231' | Only include clearances decided on or before this date, as <code>YYYYMMDD</code>. Leave empty for no ceiling. |
| `searchQuery` | `string` | no | '' | Raw openFDA search expression, ANDed with the structured filters above, e.g. <code>decision\_code:"SESE"</code>. Leave… |
| `maxResults` | `integer` | no | 100 | Stop after this many records. Each record is one billed result row. |
| `proxyConfiguration` | `object` | no | {'useApifyProxy': False} | openFDA is a public government API and does not need a proxy. Leave this off unless your account requires egress… |

#### Example input

```json
{
  "deviceClass": "2",
  "maxResults": 3,
  "proxyConfiguration": {
    "useApifyProxy": false
  }
}
```

### 📤 Output

Every row is one dataset item.

| Field | Type | Notes |
|---|---|---|
| `k_number` | `string` | openFDA 510(k) submission identifier, e.g. `K243021`. |
| `applicant` | `string` | Applicant/company that filed the 510(k). |
| `contact` | `string` | Named contact on the submission. |
| `address` | `string` | Applicant address, built from address, city, state, zip and country. |
| `device_name` | `string` | Device name as submitted. |
| `decision_code` | `string` | FDA decision code, e.g. `SESE`. |
| `decision_date` | `string` | Date FDA decided the submission (`YYYY-MM-DD`). |
| `decision_description` | `string` | Human-readable decision, e.g. `Substantially Equivalent`. |
| `product_code` | `string` | FDA product code. |
| `advisory_committee` | `string` | Advisory committee short code. |
| `advisory_committee_description` | `string` | Advisory committee full description, e.g. `Cardiovascular`. |
| `clearance_type` | `string` | Clearance pathway, e.g. `Traditional`. |
| `date_received` | `string` | Date FDA received the submission. |
| `expedited_review_flag` | `string` | Whether the submission got expedited review (`Y`/`N`). |
| `statement_or_summary` | `string` | Whether a summary or safety/effectiveness statement was filed. |
| `device_class` | `string` | FDA device class — `1`, `2` or `3`. |
| `medical_specialty_description` | `string` | Medical specialty area, e.g. `Cardiovascular`. |
| `regulation_number` | `string` | CFR regulation number governing the device, e.g. `870.2300`. |

#### Example output

```json
{
  "k_number": "K243021",
  "applicant": "ACME MEDICAL DEVICES INC.",
  "contact": "JANE DOE",
  "address": "123 MAIN ST, SPRINGFIELD, IL, US",
  "device_name": "ACME CARDIAC MONITOR",
  "decision_code": "SESE",
  "decision_date": "2024-11-15",
  "decision_description": "Substantially Equivalent",
  "product_code": "DXH",
  "advisory_committee": "CV",
  "advisory_committee_description": "Cardiovascular",
  "clearance_type": "Traditional",
  "date_received": "2024-08-01",
  "expedited_review_flag": "N",
  "statement_or_summary": "Summary",
  "device_class": "2",
  "medical_specialty_description": "Cardiovascular",
  "regulation_number": "870.2300"
}
```

### 💰 Pricing

Pay-Per-Event — you pay only when these events fire:

| Event | USD | What it is |
|---|---:|---|
| `actor-start` | $0.05 | One-off warm-up charge per run |
| `result` | $0.002 | Per dataset item |

Example: 1 000 results at the rates above ≈ **$2.05**. No subscription, no minimum, no card to start — Apify gives every new account $5 of free credit.

### 🚧 Limitations

- openFDA caps pagination at 25 000 records per query on this endpoint — narrow the search or the decision-date range to go deeper.
- Filter values aren't escaped for embedded double-quote characters — avoid quotes inside applicant, device name, or committee filters.
- Date fields are passed through in FDA's native string form rather than being reformatted.

### ❓ FAQ

**Do I need an API key?**

No. openFDA serves 510(k) data keylessly; the Actor stays inside the anonymous rate limit.

**What's the difference between this and an FDA recalls Actor?**

This Actor covers premarket 510(k) clearances — devices getting approved to market. A recalls Actor covers enforcement actions after the fact. They're separate openFDA endpoints with separate row shapes.

**Why is there a 25 000 record ceiling?**

openFDA's <code>skip</code> parameter refuses to page past 25 000 on this endpoint. The Actor stops cleanly at that boundary and logs it rather than looping or crashing.

### 💬 Your feedback

Spotted a bug, hit a weird edge case, or need a new field? Open an
issue on the Actor's **Issues** tab on Apify Console — we ship
fixes weekly and we read every report.

***

<div align="center">

Built by **[Devil Scrapes](https://apify.com/DevilScrapes)** 😈 — a small fleet of
opinionated public-data Actors. Honest pricing, real engineering, zero fine print.

</div>

# Actor input Schema

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

Filter: applicant/company name that filed the 510(k). Matches openFDA's <code>applicant</code> field.

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

Filter: device name. Matches openFDA's <code>device\_name</code> field.

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

Filter: FDA product code. Matches openFDA's <code>product\_code</code> field.

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

Filter: advisory committee description. Matches openFDA's <code>advisory\_committee\_description</code> field.

## `deviceClass` (type: `string`):

Filter: FDA device class. Matches openFDA's <code>openfda.device\_class</code> field.

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

Only include clearances decided on or after this date, as <code>YYYYMMDD</code>. Leave empty for no floor.

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

Only include clearances decided on or before this date, as <code>YYYYMMDD</code>. Leave empty for no ceiling.

## `searchQuery` (type: `string`):

Raw openFDA search expression, ANDed with the structured filters above, e.g. <code>decision\_code:"SESE"</code>. Leave empty to skip.

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

Stop after this many records. Each record is one billed result row.

## `proxyConfiguration` (type: `object`):

openFDA is a public government API and does not need a proxy. Leave this off unless your account requires egress through Apify Proxy.

## Actor input object example

```json
{
  "applicant": "Medtronic",
  "decisionDateFrom": "20240101",
  "decisionDateTo": "20241231",
  "maxResults": 100,
  "proxyConfiguration": {
    "useApifyProxy": false
  }
}
```

# Actor output Schema

## `datasetItems` (type: `string`):

All dataset items as JSON.

## `datasetItemsCsv` (type: `string`):

Same data exported to CSV.

## `datasetView` (type: `string`):

Open the run dataset in the Console.

# 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 = {
    "applicant": "Medtronic",
    "decisionDateFrom": "20240101",
    "decisionDateTo": "20241231",
    "searchQuery": "",
    "maxResults": 100,
    "proxyConfiguration": {
        "useApifyProxy": false
    }
};

// Run the Actor and wait for it to finish
const run = await client.actor("devilscrapes/fda-510k-clearances-scraper").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 = {
    "applicant": "Medtronic",
    "decisionDateFrom": "20240101",
    "decisionDateTo": "20241231",
    "searchQuery": "",
    "maxResults": 100,
    "proxyConfiguration": { "useApifyProxy": False },
}

# Run the Actor and wait for it to finish
run = client.actor("devilscrapes/fda-510k-clearances-scraper").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 '{
  "applicant": "Medtronic",
  "decisionDateFrom": "20240101",
  "decisionDateTo": "20241231",
  "searchQuery": "",
  "maxResults": 100,
  "proxyConfiguration": {
    "useApifyProxy": false
  }
}' |
apify call devilscrapes/fda-510k-clearances-scraper --silent --output-dataset

```

## MCP server setup

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

```

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/U4rRam1cnD6xBoqDx/builds/op5ZkJfH725TuNSrB/openapi.json