# FDA 510(k) Clearances Tracker: New Medical Device Approvals (`metal_spinney/fda-510k-clearances`) Actor

New FDA 510(k) medical device clearances from the official openFDA API. Filter by product code, applicant, device name and date, with a new-since-last-run mode for medtech sales, regulatory and competitive intelligence teams.

- **URL**: https://apify.com/metal_spinney/fda-510k-clearances.md
- **Developed by:** [Open Registry Data](https://apify.com/metal_spinney) (community)
- **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) Clearances Scraper + New Device Clearance Alerts

Get **every FDA 510(k) medical device clearance** as clean JSON, CSV or Excel. Data comes from the official **openFDA device/510k API** (no login, no API key), so it has no anti-bot breakage. Filter by **product code, applicant/company, device name keyword, review panel, country, clearance type and decision date range**. **Diff mode** returns only clearances that are new since your last run, which makes it a ready-made **FDA clearance alert / monitor**.

**Keywords:** FDA 510k scraper, 510(k) database, FDA device clearances, premarket notification, medical device approvals, openFDA API, K number lookup, FDA product code, De Novo, competitor monitoring, medtech intelligence, regulatory intelligence.

### Use cases

- **Medtech competitive intelligence**: get an alert when a competitor (e.g. `Medtronic`, `Siemens`) or a product code (e.g. `QIH` AI radiology software) gets a new clearance.
- **Sales and BD lead lists**: newly cleared device makers need distributors, CROs, reimbursement and regulatory consultants, contract manufacturers and marketing. Each record includes the applicant's address and contact.
- **Regulatory consultants**: benchmark review times (`reviewDays`), find predicate devices by product code, and track third-party review usage.
- **Investors and analysts**: track clearance velocity by specialty, country or company.
- **AI and RAG pipelines**: a structured, current 510(k) feed with links to the summary PDF.

### Input examples

```json
{ "productCodes": ["QIH", "LLZ"], "dateFrom": "2026-01-01" }
{ "applicants": ["Medtronic"], "lookbackDays": 60 }
{ "mode": "diff", "advisoryCommittees": ["CV"], "lookbackDays": 90, "stateKey": "cardio-watch" }
```

Filters within the same field are combined with OR, and different fields are combined with AND. Results are sorted by newest decision first.

### Output (one item per clearance)

`kNumber, deviceName, applicant, contact, address, city, state, postalCode, countryCode, dateReceived, decisionDate, reviewDays, decisionCode, decision, clearanceType, productCode, deviceClass, regulationNumber, medicalSpecialty, reviewAdvisoryCommittee, statementOrSummary, thirdPartyReview, expeditedReview, fdaDatabaseUrl, summaryPdfUrl, source` (+ `changeType, firstSeenAt, baselineRun` in diff mode).

Example (real record, Oct 2026 test run):

```json
[
  {
    "kNumber": "K260945",
    "deviceName": "Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2)",
    "applicant": "Fit-Pro KFT (Ltd.) - DBA E-Fit",
    "contact": "Janos Papp",
    "address": "Szabadság Ter. 7",
    "city": "Budapest",
    "state": null,
    "postalCode": "1054",
    "countryCode": "HU",
    "dateReceived": "2026-03-23",
    "decisionDate": "2026-09-27",
    "reviewDays": 188,
    "decisionCode": "SESE",
    "decision": "Substantially Equivalent",
    "clearanceType": "Traditional",
    "productCode": null,
    "deviceClass": null,
    "regulationNumber": null,
    "medicalSpecialty": null,
    "reviewAdvisoryCommittee": "PM",
    "statementOrSummary": "Summary",
    "thirdPartyReview": false,
    "expeditedReview": false,
    "fdaDatabaseUrl": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260945",
    "summaryPdfUrl": "https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260945.pdf",
    "changeType": "new",
    "firstSeenAt": "2026-10-07T13:46:21+00:00",
    "baselineRun": false
  }
]
```

### "New since last run" (diff mode)

Set **Mode = diff** and schedule the actor daily or weekly. Each run looks at a rolling date window and returns **only records it has never returned before**, tagged `changeType: "new"` and `firstSeenAt`. Seen IDs are stored in a named key-value store (`stateStoreName`, separate `stateKey` per saved search), so the state survives between scheduled runs. On the first run you can output the whole window (flagged `baselineRun: true`) or store a silent baseline (`firstRunBehaviour: baselineOnly`). Pair it with an Apify integration (Slack, email, Google Sheets, Zapier, Make, webhook) to get a lead alert feed.

Tip: openFDA refreshes weekly and back-fills decisions, so use a window of 60 to 90 days in diff mode. Late-arriving clearances are still caught, and duplicates never come through.

### Limits

- Keyless openFDA allows 1,000 requests/day per IP (each request returns 1,000 rows). You can add an optional `apiKey` for more.
- openFDA paging stops at 25,000 rows per query, so split very large historical pulls by date range.
- openFDA lags the FDA website by roughly 1 to 2 weeks.

### Source and licence

Data from **openFDA** (U.S. Food and Drug Administration), public domain / CC0 (https://open.fda.gov/license/). Every item carries a `source` attribution block. This actor is not affiliated with or endorsed by FDA. openFDA's disclaimer applies: do not rely on openFDA for medical care decisions, and treat results as unvalidated.

### Row cap and failure handling

- **`maxRowsPerSource`** (default 5000, 0 = unlimited): per-source cap on raw rows fetched, with automatic pagination. Sources that hit the cap are listed under `cappedSources` in the `OUTPUT` record and in the run's status message.
- **Failures are loud**: if any source fails (HTTP error, ArcGIS error, timeout), the run is marked **FAILED**, the status message names the failed source(s) and error, and the `OUTPUT` key-value record contains `ok: false` and `failedSources`. Rows from a failed source are never returned partially.

# Actor input Schema

## `mode` (type: `string`):

Diff mode remembers IDs already returned (named key-value store) and outputs only new ones. Schedule it daily/weekly for alerts.

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

3-letter product codes, e.g. QIH (AI radiology software), LLZ (image processing), DQY, FRO.

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

Company name phrase match, e.g. Medtronic, Siemens, GE Healthcare.

## `deviceNameKeywords` (type: `array`):

Word/phrase match on device name, e.g. catheter, AI, robot.

## `advisoryCommittees` (type: `array`):

e.g. RA (radiology), CV (cardiovascular), OR (orthopedic), NE (neurology), SU (surgery).

## `countryCodes` (type: `array`):

ISO-2, e.g. US, CN, KR, DE.

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

e.g. SESE (substantially equivalent). Empty = all.

## `clearanceType` (type: `string`):

510(k) pathway (Direct = De Novo).

## `dateFrom` (type: `string`):

Decision date from (YYYY-MM-DD).

## `dateTo` (type: `string`):

Decision date to.

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

Decision-date window when Date from is empty (diff mode tip: 90, openFDA updates weekly and back-fills).

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

0 = no limit.

## `maxRowsPerSource` (type: `integer`):

Per-source row cap (paginated). 0 = no limit. The run status/OUTPUT record flags sources that hit the cap.

## `stateKey` (type: `string`):

Use a different key per saved search/schedule so their 'seen' lists don't mix.

## `stateStoreName` (type: `string`):

Named key-value store holding the seen-ID state. Leave empty for the default.

## `firstRunBehaviour` (type: `string`):

What the first diff run (no state yet) returns.

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

Not required. Keyless = 1,000 requests/day per IP, plenty for this actor.

## Actor input object example

```json
{
  "mode": "snapshot",
  "productCodes": [
    "QIH"
  ],
  "clearanceType": "any",
  "lookbackDays": 30,
  "maxItems": 0,
  "maxRowsPerSource": 5000,
  "stateKey": "default",
  "firstRunBehaviour": "emitAll"
}
```

# Actor output Schema

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

No description

## `resultsView` (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 = {
    "productCodes": [
        "QIH"
    ]
};

// Run the Actor and wait for it to finish
const run = await client.actor("metal_spinney/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 = { "productCodes": ["QIH"] }

# Run the Actor and wait for it to finish
run = client.actor("metal_spinney/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 '{
  "productCodes": [
    "QIH"
  ]
}' |
apify call metal_spinney/fda-510k-clearances --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,metal_spinney/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/gzl3fav39bXBwVfxS/builds/FxZG5FAFRVgpyyraP/openapi.json