510(k) Report
Know your predicate options before you file.
A research report for a FKX device built from FDA’s public records: candidate predicates ranked, every recall in their family trees, and how long reviews in the product code take.
Order
Get a report for your device
$995USD, one price
- Describe the device and pay.A few sentences on what it does, who it is for and how it works. Card payment through Stripe.
- Answer a few questions.A private page of questions written for your device. Skip any you cannot answer yet.
- Get the report by email.A PDF, usually within a few hours of your answers.
What the report contains
- Classification and pathway
The product code, class and regulation that fit the device, and whether it needs a 510(k) at all: FDA’s rule for the code, and each limit on an exemption tested against your device.
- Ranked candidate predicates
Up to ten cleared devices to claim equivalence to, ranked by how closely each fits your device, read from its FDA summary, with the side-by-side differences a reviewer would raise.
- Family-tree risk
For each candidate, its line of descent and every recall in its family, with Class I recalls called out.
- Review-time outlook
How long 510(k) reviews in the code take, the spread, and the trend over recent years.
- Post-market context
Recalls by class and root cause, and adverse event reports per year for the code.
- Sources and method
Every figure linked to its FDA record or summary page, with the extraction method and its measured accuracy.
Free pages and the report
| Free device and category pages | 510(k) Report | |
|---|---|---|
| Starting point | One cleared device or product code | Your device concept |
| Predicates | The ones this device cited | Candidates for your device, ranked and compared |
| Recall history | This device and its family tree | Every candidate’s family, side by side |
| Review times | This device against its code | The outlook for your submission, with the trend |
| Format | Web page | A written report with sources, ready to share |
Questions
Who is the 510(k) Report for?
Founders, product teams and regulatory consultants planning a 510(k) or De Novo submission who want the predicate landscape, recall history and review times for a device type in one document.
What do you need from me?
What the device does, who it is for and how it works. If you know the product code or a likely predicate, include it; if not, we work it out. After payment you get a private page of questions written for your device. Answer what you can, and anything you skip stays in the report as an open question.
How long does it take?
The report is built from your answers and emailed to you as a PDF, usually within a few hours of sending them.
How is it different from the free pages?
The free pages show one device or one product code at a time. The report starts from your device concept, compares candidate predicates side by side, and weighs their families’ recall histories and review times.
Is the report regulatory advice?
It is research built from FDA’s public records. It shows the evidence and the method behind every figure so your regulatory team can use it in their own judgement.
Ready when you are. $995 USD, one price. Describe the device and pay; the report arrives by email, usually within a few hours of your answers.
Order a report, $995