Map a medical-device category

You are assessing a device category, or preparing for a conversation about one, and need the public record in one place.

Who this is for

Written for Medtech startups, regulatory consultants. You bring the commercial question; the published record behind it comes back with the answer, and you can see where each figure came from.

What to bring

Have these to hand before you paste the prompt. Anything you leave out should be asked for rather than guessed at.

The product code or device category
The period to cover

Try this prompt

Paste this where you connected HARBOR Port and replace the bracketed parts. It asks for sources and periods on purpose: that is what makes the answer checkable.

For device category or product code [code], summarise its classification, the recent clearances, and the relevant recall and adverse-event records from [period]. Keep every record linked, distinguish a reported event from confirmed causation, and do not infer safety or market share from a count.

Then ask a narrower question. These are the ones people ask next.

Which applicants have cleared the most devices in this category.

How do the adverse-event reports break down by event type.

What the answer looks like

The shape below is the point of the workflow. If a response arrives without the periods and the source behind each number, ask for them before you use it.

Classification and what it means for the category
Recent clearances with applicant and date
Recalls and adverse events, linked and counted
An explicit statement that reports are not causation

Limits to keep in view

Adverse-event records are reports. A report is not established causation, and a count is not a safety ranking.

Census, BEA and BLS series are published on different calendars and for different periods. Every figure carries the period and geography that were actually returned, not the one that was asked for.

Not answered by this data:

Your revenue, customers, bookings, pipeline or churn
Inventory, capacity, staffing rosters or payroll
Your actual utility bills, fuel spend or supplier quotes
Business credit, insurance premiums, or lending decisions
Permit, licence or certification status
A local forecast, a hazard estimate, or a legal opinion

Where the numbers come from

The answer is built from the published sources below. Each one keeps its own geography, period and definitions, and the answer states which was used.

openFDA device classification, clearances, recalls and adverse events

The exact names, and where to read the detail

openfda

openfda_device_classification_lookup
openfda_device_510k_clearances
openfda_device_recalls_recent
openfda_device_adverse_events

Scoped to what your plan reaches, and to the sources each workflow names. Reviewing the catalogue first is the cheap way to decide whether this covers your question: source catalogue.