# FDA 510(k) Clearances + Startup Stage & Review Signals (`grandiose_envelope_0fj/openfda-510k-pma-medical-device-clearances-scraper`) Actor

🔗 \[Multi-Source Cross-Joined] Extract newly cleared FDA 510(k) medical devices with applicant contact person, cross-joined Device Class (I/II/III), FEI number, Applicant Lifetime 510(k) Count (First-Time MedTech Startup vs Enterprise OEM), and FDA Review Duration days.

- **URL**: https://apify.com/grandiose_envelope_0fj/openfda-510k-pma-medical-device-clearances-scraper.md
- **Developed by:** [Olive LI](https://apify.com/grandiose_envelope_0fj) (community)
- **Categories:** Lead generation, Agents, Integrations
- **Security:** Limited permissions
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $3.20 / 1,000 cross-joined enriched lead / records

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) & De Novo Medical Device Clearances B2B Lead Intelligence Scraper

**100% Entity-Pure Relational `LEFT JOIN` MedTech Lead Engine (`1 Row = 1 Recently Cleared FDA 510(k) Submission`)** enriched across **5 Authoritative Public APIs** for Immediate Import into **Instantly.ai, Smartlead, Clay.com, Orum/Nooks, and HubSpot/Salesforce**.

***

### 1. Who Buys This Data & How They Use It

When a medical device manufacturer receives **FDA 510(k) Clearance (`SESE`)**, an immediate 30-to-90-day commercial execution window opens. The company must transition from regulatory review into commercial manufacturing, sterile packaging, GUDID/UDI labeling, hospital supply-chain onboarding, and post-market surveillance.

#### Target Paying Buyer Personas

1. **Medical Device Contract Manufacturers (CMOs / CDMOs) & Sterilization / Packaging Vendors**:
   - Filter by `applicant_total_510k_clearances_num <= 5` (`EMERGING_MEDTECH_ENTRANT`) or `establishment_role = "Develop Specifications But Do Not Manufacture At This Facility"` to identify specification developers and emerging MedTech companies that outsource production, molding, and EO/gamma sterilization.
2. **QA/RA Regulatory & Post-Market Surveillance (PMS) Consultants**:
   - Filter by `review_days_num > 180` (`EXTENDED_MULTI_ROUND_REVIEW`) or `category_maude_adverse_events_num >= 5000` (`HIGH_SCRUTINY_DEVICE_CATEGORY`) to pitch 21 CFR Part 820 QMSR audits, MDR complaint handling, and EU MDR transition support directly to the named 510(k) regulatory correspondent.
3. **MedTech 3PL Logistics, GPO Contracting & Hospital Distribution Agencies**:
   - Filter by `applicant_country != "US"` (`CH`, `DE`, `GB`, `IL`, `TW`, `BR`, `KR`) or `commercial_distribution_status` to target foreign MedTech manufacturers that just cleared FDA review and need US 3PL warehousing, importer representation, and IDN/GPO hospital sales teams.
4. **Vertical B2B SaaS SDRs (eQMS, UDI Compliance, Clinical/ERP Software)**:
   - Import `contact_first_name`, `contact_last_name`, `contact_email`, `company_clean_name`, `company_domain`, and `outreach_icebreaker` directly into **Instantly.ai, Smartlead, or Clay.com**; dial `contact_phone_e164` in **Orum / Nooks** using `cold_call_opening_hook`.

***

### 2. Relational `LEFT JOIN` Architecture (Zero `UNION ALL`)

Unlike raw openFDA scrapers that dump unjoined ALL-CAPS records without domains, emails, phones, or facility registrations, every row represents **1 Recently Cleared FDA 510(k) Submission (`k_number`)** enriched via 4 relational `LEFT JOIN` steps:

| Join Step | Authoritative Data Source | Join Key | Enriched Fields & Derived Signals |
| :--- | :--- | :--- | :--- |
| **Base Entity** | **openFDA 510(k) Clearances API** (`api.fda.gov/device/510k.json`) | `k_number` | `k_number`, `submission_type`, `date_received`, `decision_date`, `review_days_num`, `review_speed_tier`, `device_clean_name`, `product_code`, `medical_specialty`, `device_class_num`, `regulation_number`, split `contact_first_name` & `contact_last_name` |
| **`LEFT JOIN 1`** | **openFDA Historical Portfolio API** (`api.fda.gov/device/510k.json?search=applicant:...`) | `applicant` / `core_search_name` | `applicant_total_510k_clearances_num`, `medtech_commercial_stage_signal` (`EMERGING_MEDTECH_ENTRANT` vs. `GROWTH_STAGE_MEDTECH` vs. `ENTERPRISE_MEDTECH_OEM`) |
| **`LEFT JOIN 2`** | **openFDA Establishment Registration & UDI/GUDID APIs** (`registrationlisting.json` + `udi.json`) | Verified `registration.name` / `owner_operator.firm_name` / `company_name` | `fda_registration_number`, `fda_fei_number`, `owner_operator_number`, `establishment_role`, `udi_public_device_records_num`, `commercial_distribution_status`, official correspondent phone & GUDID customer contact email/phone |
| **`LEFT JOIN 3`** | **openFDA MAUDE Adverse Event & Recall APIs** (`event.json` + `recall.json`) | `product_code` | `category_maude_adverse_events_num`, `category_recalls_num`, `post_market_surveillance_risk_tier` |
| **`LEFT JOIN 4`** | **FDA GUDID + Clearbit Autocomplete Domain Resolution** | Verified brand tokens | `company_clean_name`, `company_domain`, `company_website_url`, `contact_email`, `email_resolution_source`, `fda_us_agent_email`, `contact_phone_e164`, `contact_phone_formatted` |

***

### 3. Complete 48-Column Output Schema (7-Gate Buyer-Ready Standard)

| Field | Type | Description |
| :--- | :--- | :--- |
| `k_number` | `string` | Primary entity key: Official FDA 510(k) or De Novo clearance number (e.g., `K262080`) |
| `submission_type` | `string` | `Traditional 510(k)`, `Special 510(k)`, `Dual Track 510(k)`, or `De Novo Classification` |
| `decision_code` | `string` | FDA decision code (e.g., `SESE`) |
| `decision_description` | `string` | Official FDA clearance determination (`Substantially Equivalent`) |
| `date_received` | `string` | ISO `YYYY-MM-DD` date FDA received the submission |
| `decision_date` | `string` | ISO `YYYY-MM-DD` date FDA issued clearance |
| `review_days_num` | `string` | Pure numeric calendar days in FDA review (e.g., `123`) |
| `review_speed_tier` | `string` | Derived review friction tier (`FAST_TRACK_CLEARANCE`, `STANDARD_FDA_REVIEW`, `EXTENDED_MULTI_ROUND_REVIEW`) |
| `company_clean_name` | `string` | Clean Title Case company name stripped of `Inc.`, `LLC`, `GmbH`, `AG`, `Ltd.` for cold email merge tags |
| `applicant_legal_name` | `string` | Official FDA applicant legal entity name |
| `company_domain` | `string` | Verified root domain (e.g., `cascination.com`, `globusmedical.com`) |
| `company_website_url` | `string` | Full HTTPS company website URL |
| `device_clean_name` | `string` | Human-readable Title Case device name stripped of SKU lists, catalog codes, and symbols |
| `device_raw_name` | `string` | Original proprietary device name string filed with FDA |
| `product_code` | `string` | 3-letter FDA product classification code |
| `medical_specialty` | `string` | FDA Advisory Committee medical specialty panel |
| `device_class_num` | `string` | Pure numeric FDA risk class (`1`, `2`, or `3`) |
| `device_risk_class` | `string` | Formatted risk class (`Class I`, `Class II`, `Class III`) |
| `regulation_number` | `string` | 21 CFR citation (e.g., `892.2050`) |
| `contact_first_name` | `string` | Clean Title Case first name of the official 510(k) regulatory contact |
| `contact_last_name` | `string` | Clean Title Case last name of the official 510(k) regulatory contact |
| `contact_full_name` | `string` | Full human name of the official 510(k) correspondent |
| `contact_credentials` | `string` | Extracted credentials (`PhD`, `MD`, `RAC`) or `None Listed` |
| `contact_role_title` | `string` | `Official 510(k) Regulatory Correspondent` |
| `contact_email` | `string` | Single atomic email resolved via FDA GUDID, FDA Registration, or verified corporate domain |
| `email_resolution_source` | `string` | Provenance of `contact_email` |
| `fda_us_agent_email` | `string` | Official FDA-registered US Agent email for foreign manufacturers |
| `contact_phone_e164` | `string` | E.164 phone number (`+16109301800`, `+41313062653`) |
| `contact_phone_formatted` | `string` | Human-readable formatted phone (`(610) 930-1800`) |
| `applicant_street_address` | `string` | Street address of the applicant facility |
| `applicant_city` | `string` | Applicant city |
| `applicant_state` | `string` | 2-letter US state or international region code |
| `applicant_zip` | `string` | Applicant postal / ZIP code |
| `applicant_country` | `string` | 2-letter ISO country code (`US`, `CH`, `GB`, `DE`, `IL`, `TW`, `BR`) |
| `applicant_total_510k_clearances_num` | `string` | `LEFT JOIN 1`: Total lifetime FDA 510(k) clearances held by this applicant |
| `medtech_commercial_stage_signal` | `string` | `LEFT JOIN 1`: Derived commercial stage signal |
| `fda_registration_number` | `string` | `LEFT JOIN 2`: Verified FDA Establishment Registration Number |
| `fda_fei_number` | `string` | `LEFT JOIN 2`: Verified FDA Establishment Identifier (FEI) |
| `owner_operator_number` | `string` | `LEFT JOIN 2`: Verified FDA Owner/Operator Number |
| `establishment_role` | `string` | `LEFT JOIN 2`: Registered establishment role (`Manufacture Medical Device`, `Specification Developer`) |
| `udi_public_device_records_num` | `string` | `LEFT JOIN 2`: Count of published GUDID/UDI device records |
| `commercial_distribution_status` | `string` | `LEFT JOIN 2`: GUDID commercial distribution status |
| `category_maude_adverse_events_num` | `string` | `LEFT JOIN 3`: Total MAUDE adverse event reports for this `product_code` |
| `category_recalls_num` | `string` | `LEFT JOIN 3`: Total FDA recalls for this `product_code` |
| `post_market_surveillance_risk_tier` | `string` | `LEFT JOIN 3`: Derived post-market surveillance risk tier |
| `fda_summary_url` | `string` | Direct URL to the official FDA CDRH 510(k) / De Novo record |
| `outreach_icebreaker` | `string` | Plug-and-play personalized cold email opening sentence |
| `cold_call_opening_hook` | `string` | Plug-and-play power-dialer opening script |

# Actor input Schema

## `searchKeyword` (type: `string`):

Filter by specialty, device name, or applicant (e.g., 'Radiology', 'Cardiovascular', 'Orthopedic', 'AI', or leave empty for latest).

## `countryCode` (type: `string`):

Two-letter country code filter (leave empty for global).

## `crossJoinApplicantHistory` (type: `boolean`):

Automatically query openFDA historical totals per applicant to distinguish 1st-time MedTech startups from large OEMs.

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

Maximum number of enriched 510(k) leads to return (1 to 50,000).

## Actor input object example

```json
{
  "searchKeyword": "",
  "countryCode": "",
  "crossJoinApplicantHistory": true,
  "maxItems": 20
}
```

# Actor output Schema

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

🔗 \[Multi-Source Cross-Joined] Extract newly cleared FDA 510(k) medical devices with applicant contact person, cross-joined Device Class (I/II/III), FEI number, Applicant Lifetime 510(k) Count (First-Time MedTech Startup vs Enterprise OEM), and FDA Review Duration days.

# 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 = {
    "searchKeyword": "",
    "countryCode": "",
    "maxItems": 20
};

// Run the Actor and wait for it to finish
const run = await client.actor("grandiose_envelope_0fj/openfda-510k-pma-medical-device-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 = {
    "searchKeyword": "",
    "countryCode": "",
    "maxItems": 20,
}

# Run the Actor and wait for it to finish
run = client.actor("grandiose_envelope_0fj/openfda-510k-pma-medical-device-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 '{
  "searchKeyword": "",
  "countryCode": "",
  "maxItems": 20
}' |
apify call grandiose_envelope_0fj/openfda-510k-pma-medical-device-clearances-scraper --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,grandiose_envelope_0fj/openfda-510k-pma-medical-device-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/ZnJD7aMSldM5BAaAM/builds/ypGQlYjL7zUYJeOIY/openapi.json