# fda_device_510k

FDA 510(k) clearances for medical devices. The 510(k) pathway is how most non-high-risk devices come to market in the US. Filter by manufacturer (applicant), device name, product code, or decision date range. Used for competitive intel, device R&D scouting, M&A research.

Agent View of the PolicyLayer registry record for `fda_device_510k`. HTML page: https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/fda-device-510k

## Facts

- Tool: `fda_device_510k`
- Server: Livedatalink (`https://livedatalink.ai/mcp`) — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink.md
- Homepage: https://github.com/blackboxfoundry/livedatalink
- Risk category: Read (Low risk)
- Registry record: grade F, identity unverified
- Server auth posture: open
- Server CORS policy: *
- Server rate-limited: no
- Parameters: 5
- Recommended policy verdict: Allowed

## Parameters

| Parameter | Type | Required | Description |
| --- | --- | --- | --- |
| `limit` | number | no | Maximum rows to return (default 25, max 100). |
| `query` | string | no | Manufacturer (applicant) name or device name search term. |
| `end_date` | string | no | Inclusive ISO date upper bound (YYYY-MM-DD). |
| `start_date` | string | no | Inclusive ISO date lower bound (YYYY-MM-DD). |
| `product_code` | string | no | Optional product code (e.g. 'DXJ' for ECG). |

Parameters from the server's own tool schema.

## Example call (MCP tools/call, JSON-RPC 2.0)

```json
{
  "jsonrpc": "2.0",
  "id": 1,
  "method": "tools/call",
  "params": {
    "name": "fda_device_510k",
    "arguments": {}
  }
}
```

## Why fda_device_510k is rated Low

This tool queries a public FDA database to retrieve historical medical device clearance information. It has no side effects, cannot modify records, execute commands, or affect financial systems. The blast radius of misuse is minimal—an agent could only retrieve existing public data about device clearances. No irreversible actions or external operations are triggered.

From the tool's own definition: "Tool retrieves FDA 510(k) clearance data with filtering options (manufacturer, device name, product code, decision date); no modification, deletion, or execution capability described."

## Use case

AI agents call fda_device_510k to retrieve information from Livedatalink without modifying anything. It is typically the context-gathering step in research, monitoring, and reporting workflows, before the agent takes action elsewhere.

## Recommended policy (PolicyLayer)

Verdict: **Allowed**. Enforced by the PolicyLayer MCP gateway (https://policylayer.com/mcp-gateway) before a call reaches Livedatalink:

```json
{
  "version": "1",
  "default": "deny",
  "tools": {
    "fda_device_510k": {}
  }
}
```

## Other tools on Livedatalink (279)

- `beneficial_owner_screen` — Destructive — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/beneficial-owner-screen.md
- `cdc_dataset_query` — Execute — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/cdc-dataset-query.md
- `clinical_site_selector` — Execute — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/clinical-site-selector.md
- `air_quality` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/air-quality.md
- `bank_health_report` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/bank-health-report.md
- `bls_indicator` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/bls-indicator.md
- `bls_series` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/bls-series.md
- `book_details` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/book-details.md
- `book_fulltext_search` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/book-fulltext-search.md
- `book_get_text` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/book-get-text.md
- `book_search` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/book-search.md
- `book_status` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/book-status.md
- `bounce_scanner` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/bounce-scanner.md
- `candlestick_signals` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/candlestick-signals.md
- `cargo_crate` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/cargo-crate.md
- `carrier_vetting_score` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/carrier-vetting-score.md
- `caselaw_case_details` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/caselaw-case-details.md
- `caselaw_citation_lookup` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/caselaw-citation-lookup.md
- `caselaw_opinion_text` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/caselaw-opinion-text.md
- `caselaw_search` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/caselaw-search.md
- `cdc_drug_overdose_deaths` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/cdc-drug-overdose-deaths.md
- `cdc_excess_deaths_covid` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/cdc-excess-deaths-covid.md
- `cdc_flu_surveillance` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/cdc-flu-surveillance.md
- `cdc_leading_causes_of_death` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/cdc-leading-causes-of-death.md
- `cdc_outbreak_reports` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/cdc-outbreak-reports.md
- `cdc_vaccination_coverage` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/cdc-vaccination-coverage.md
- `cdc_weekly_deaths_by_state` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/cdc-weekly-deaths-by-state.md
- `census_business` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/census-business.md
- `census_commute_employment` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/census-commute-employment.md
- `census_demographics` — Read — https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink/census-demographics.md
- …and 249 more: https://policylayer.com/tools/io-github-blackboxfoundry-livedatalink.md

## For agents

This record is a snapshot. Live verdicts and the full registry:

- Check every server in your MCP config at once: `npx -y policylayer stack`
- Vet a server before you add it: install the mcp-precheck skill — `npx skills add https://policylayer.com` (skill text: https://policylayer.com/skill.md)
- Query the registry over MCP: endpoint `https://api.policylayer.com/mcp` — tools `check_mcp_server`, `check_mcp_stack`, `check_tool`, `search_registry`, `get_change_events`

---

Source: the PolicyLayer MCP registry — one continuously verified record per MCP server. Full record: https://policylayer.com/registry?q=io-github-blackboxfoundry-livedatalink · API: https://policylayer.com/registry/api · Policy library: https://policylayer.com/policies/io-github-blackboxfoundry-livedatalink