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FDA 510 premarket notifications: K-number, device name

health_fda_medical_device_510k
Read-only

FDA 510(k) premarket notifications (openFDA): K-number, device name, applicant, decision (e.g. Substantially Equivalent), decision and received dates, product code and advisory committee. Up to 10 per call. Related tools on this server, for a different need: health_fda_device_gudid when you need FDA GUDID device record by Device Identifier: brand; health_fda_drug_shortages when you need FDA drug shortage listings: generic name, availability. Price: $0.002 in USDC per successful call, paid with x402 (Base, Solana or Arc); failed calls are not charged.

Input Schema

NameRequiredDescriptionDefault
qYesDevice name words, letters, digits and spaces, 2 to 60 characters
maxNoHow many clearances, 1 to 10 (default 5)

Output Schema

NameRequiredDescriptionDefault
queryNo
totalNo
sourceNo
checkedAtNo
clearancesNo

Schema Changelog

Changes observed during successful MCP inspections.

  1. First observed

TDQS

A4.1/5.0
Behavior4/5

Does the description disclose side effects, auth requirements, rate limits, or destructive behavior?

Annotations already cover read-only and open-world behavior, and the description adds material context the annotations do not: a $0.002 USDC charge per successful call via x402 on Base/Solana/Arc, no charge on failure, and a hard cap of 10 results per call. Missing only details like rate limits or latency, so it is solid but not exhaustive.

Agents need to know what a tool does to the world before calling it. Descriptions should go beyond structured annotations to explain consequences.

Conciseness4/5

Is the description appropriately sized, front-loaded, and free of redundancy?

Field list and the results-per-call cap are front-loaded, followed by compact sibling routing and pricing. The enumerated field list and pricing sentence are dense but each carries information an agent needs; minor redundancy with the output schema prevents a 5.

Shorter descriptions cost fewer tokens and are easier for agents to parse. Every sentence should earn its place.

Completeness4/5

Given the tool's complexity, does the description cover enough for an agent to succeed on first attempt?

The tool has an output schema, so return details are already structured, yet the description still summarizes the record fields and adds cost and result-cap behavior, leaving little an agent needs unknowable before calling. Only permission/payment-flow mechanics and any pagination or total-count behavior are unaddressed.

Complex tools with many parameters or behaviors need more documentation. Simple tools need less. This dimension scales expectations accordingly.

Parameters3/5

Does the description clarify parameter syntax, constraints, interactions, or defaults beyond what the schema provides?

Schema coverage is 100% — 'q' is documented as 2-60 characters of device name and 'max' as 1-10 with a default of 5. The description's 'Up to 10 per call' merely restates the max bound, adding no syntax, matching behavior, or format detail beyond the schema, so the baseline 3 applies.

Input schemas describe structure but not intent. Descriptions should explain non-obvious parameter relationships and valid value ranges.

Purpose5/5

Does the description clearly state what the tool does and how it differs from similar tools?

The description names a specific resource (FDA 510(k) premarket notifications from openFDA) and enumerates the returned fields (K-number, device name, applicant, decision, dates, product code, advisory committee), which is far more precise than the title alone. It is clearly separable from device, drug-shortage, and other FDA siblings.

Agents choose between tools based on descriptions. A clear purpose with a specific verb and resource helps agents select the right tool.

Usage Guidelines4/5

Does the description explain when to use this tool, when not to, or what alternatives exist?

It explicitly routes the agent away for two adjacent needs: health_fda_device_gudid for Device Identifier lookups and health_fda_drug_shortages for shortage listings. It does not address other plausibly confusable FDA siblings (e.g. recalls/enforcement, Orange Book), but the stated alternatives establish a clear usage context.

Agents often have multiple tools that could apply. Explicit usage guidance like "use X instead of Y when Z" prevents misuse.

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