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AI Vendor Terms
In development

510(k) Product-Code Brief

A planned brief on the medical devices the FDA (Food and Drug Administration) clears through 510(k) premarket notification, one device product code at a time. It will show which companies are getting cleared in that code, how long FDA has taken to decide compared with the past year, and the recalls in the same code, all from FDA’s public data.

In development. Not for sale yet: no price and no release date.

What it will cover

  • New clearances in the product code, with the applicant and the type of clearance
  • Median days from submission to decision, against the past 12 months
  • The companies with the most clearances in the code
  • Recalls by class, and counts of reported adverse events

Who it is for

  • Regulatory affairs leads at device companies

    See how long recent decisions in your product code took before you submit.

  • Business development leads

    Know which competitors are getting cleared, and what to tell sales after a rival’s recall.

  • Regulatory consultants

    Start from a product-code summary instead of building one by hand for each client.

Sources it will use

How it will be made

  • Linked to FDA

    Each clearance and recall links back to its FDA record, and each brief states the date of the FDA data it uses.

  • Numbers come from code

    Counts and median decision times are computed by code from FDA’s records and footnoted.

  • Not regulatory advice

    The brief reports what FDA’s records show. It does not tell you how to file.

Status

In development

We are building this report. It has no price and cannot be bought, and we have not set a release date. This page describes what the report will contain. None of it is a finding yet.

If you would use it, email support@dimdrop.com with the report name and what you would use it for. It helps us decide what to build next.

The report on sale today is the AI Vendor Terms Monitor.