# medical.device-510k

FDA 510(k) premarket clearances — medical devices cleared for US marketing via substantial equivalence. Search by device name, applicant (manufacturer), or FDA product code; returns K-number, device name, applicant, decision date + description, clearance type, product code, advisory committee, newest first. Free, public-domain FDA data.

Agent View of the PolicyLayer registry record for `medical.device-510k`. HTML page: https://policylayer.com/tools/io-github-2s-io-mcp/medical.device-510k

## Facts

- Tool: `medical.device-510k`
- Server: Mcp (`@2sio/mcp`) — https://policylayer.com/tools/io-github-2s-io-mcp.md
- Install: `npx -y @2sio/mcp`
- Homepage: https://github.com/2s-io/sdk
- Risk category: Read (Low risk)
- Registry record: grade F, identity unverified
- Server rate-limited: no
- Parameters: 0
- Recommended policy verdict: Allowed

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

```json
{
  "jsonrpc": "2.0",
  "id": 1,
  "method": "tools/call",
  "params": {
    "name": "medical.device-510k",
    "arguments": {}
  }
}
```

## Why medical.device-510k is rated Low

This is a read-only query tool that retrieves public-domain FDA regulatory information. It has no side effects, cannot modify data, and poses minimal risk even if misused by an AI agent—the worst outcome would be retrieval of publicly available regulatory records. The 2s.io payment mechanism is external to the tool's function.

From the tool's own definition: "Tool provides search and retrieval of FDA 510(k) premarket clearance data: 'Search by device name, applicant (manufacturer), or FDA product code; returns K-number, device name, applicant, decision date + description, clearance type, product code, advisory…"

## Use case

AI agents call medical.device-510k to retrieve information from Mcp 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 Mcp:

```json
{
  "version": "1",
  "default": "deny",
  "tools": {
    "medical.device-510k": {}
  }
}
```

## Other tools on Mcp (571)

- `queue.ack` — Destructive — https://policylayer.com/tools/io-github-2s-io-mcp/queue.ack.md
- `store.blob-delete` — Destructive — https://policylayer.com/tools/io-github-2s-io-mcp/store.blob-delete.md
- `store.doc-delete` — Destructive — https://policylayer.com/tools/io-github-2s-io-mcp/store.doc-delete.md
- `store.kv-delete` — Destructive — https://policylayer.com/tools/io-github-2s-io-mcp/store.kv-delete.md
- `store.vector-delete` — Destructive — https://policylayer.com/tools/io-github-2s-io-mcp/store.vector-delete.md
- `watchers.cancel` — Destructive — https://policylayer.com/tools/io-github-2s-io-mcp/watchers.cancel.md
- `ai.council` — Execute — https://policylayer.com/tools/io-github-2s-io-mcp/ai.council.md
- `ai.screenshot` — Execute — https://policylayer.com/tools/io-github-2s-io-mcp/ai.screenshot.md
- `batch.run` — Execute — https://policylayer.com/tools/io-github-2s-io-mcp/batch.run.md
- `dev.preflight` — Execute — https://policylayer.com/tools/io-github-2s-io-mcp/dev.preflight.md
- `dev.regex-test` — Execute — https://policylayer.com/tools/io-github-2s-io-mcp/dev.regex-test.md
- `hash.compute` — Execute — https://policylayer.com/tools/io-github-2s-io-mcp/hash.compute.md
- `pubsub.subscribe` — Execute — https://policylayer.com/tools/io-github-2s-io-mcp/pubsub.subscribe.md
- `queue.lease` — Execute — https://policylayer.com/tools/io-github-2s-io-mcp/queue.lease.md
- `search.crawl` — Execute — https://policylayer.com/tools/io-github-2s-io-mcp/search.crawl.md
- `url.render` — Execute — https://policylayer.com/tools/io-github-2s-io-mcp/url.render.md
- `watchers.crypto-address-activity` — Execute — https://policylayer.com/tools/io-github-2s-io-mcp/watchers.crypto-address-activity.md
- `watchers.earthquake` — Execute — https://policylayer.com/tools/io-github-2s-io-mcp/watchers.earthquake.md
- `predict.crypto-updown` — Financial — https://policylayer.com/tools/io-github-2s-io-mcp/predict.crypto-updown.md
- `predict.wallet` — Financial — https://policylayer.com/tools/io-github-2s-io-mcp/predict.wallet.md
- `watchers.fear-greed` — Financial — https://policylayer.com/tools/io-github-2s-io-mcp/watchers.fear-greed.md
- `watchers.fx-rate` — Financial — https://policylayer.com/tools/io-github-2s-io-mcp/watchers.fx-rate.md
- `agent.knowledge-delta` — Other — https://policylayer.com/tools/io-github-2s-io-mcp/agent.knowledge-delta.md
- `agriculture.drought` — Read — https://policylayer.com/tools/io-github-2s-io-mcp/agriculture.drought.md
- `agriculture.stats` — Read — https://policylayer.com/tools/io-github-2s-io-mcp/agriculture.stats.md
- `ai.chat` — Read — https://policylayer.com/tools/io-github-2s-io-mcp/ai.chat.md
- `ai.classify` — Read — https://policylayer.com/tools/io-github-2s-io-mcp/ai.classify.md
- `ai.describe-image` — Read — https://policylayer.com/tools/io-github-2s-io-mcp/ai.describe-image.md
- `ai.entities` — Read — https://policylayer.com/tools/io-github-2s-io-mcp/ai.entities.md
- `ai.extract` — Read — https://policylayer.com/tools/io-github-2s-io-mcp/ai.extract.md
- …and 541 more: https://policylayer.com/tools/io-github-2s-io-mcp.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-2s-io-mcp · API: https://policylayer.com/registry/api · Policy library: https://policylayer.com/policies/io-github-2s-io-mcp