510(k) Gap Assessment
A written comparison between what your device already has and what a 510(k) requires.
It names each missing item, the cost of obtaining it, and the lead time. That supports the two decisions in front of you: whether to file at all, and what to budget if you do.
The assessment is free because a fixed price for the build is only honest once someone has read your actual documents. It is what turns our $11,000 to $20,000 range into your number.
- Our fee
- No charge
- You get
- A written report
- Predicate
- Named, with its K-number
- You send
- Your device documents
- It decides
- Your 510(k) build price
- Checked by
- A named specialist
Eight answers, in writing, that you keep.
Every one of them is a thing you would otherwise have to discover by spending money and finding out.
Product code and class
Confirmed against FDA's classification database, not inferred from your description.
The pathway
Whether a 510(k) is required, exempt, or whether another route applies to you.
A recommended predicate
With the K-number, and the reasoning for choosing that one over the alternatives.
Testing you already hold
Every report you have, assessed against the standards FDA recognizes.
Testing you do not
Every test still outstanding, with typical laboratory cost and lead time.
The FDA fee
The one that will apply to you, including whether you qualify for the small business rate.
A realistic timeline
To submission, and from submission to decision — the median for devices like yours from FDA's own records.
A named reviewer
The regulatory affairs professional who checked the assessment before it was sent to you.
One choice governs the entire file.
Your predicate is the cleared device your submission is measured against. The one we recommend is a device FDA has already accepted in your category — not a guess from a keyword search of the public index.
You get the K-numbers and the reasoning, including for the ones we rejected, so you can check every one yourself before deciding anything. And where another route suits your device better than a 510(k), the report tells you at the start — so everything you spend afterwards goes towards the pathway that gets you cleared.
- K-numberRecommended
Same product code, comparable technology, and indications your existing evidence already supports.
- K-numberRejected
Close on technology, but its cleared indications are wider than yours. Matching it would mean testing you do not need.
- K-numberRejected
Right indications, different operating principle. The comparison would not hold up.
Every K-number in the report is checkable in FDA's public index before you commit to anything.
The documents themselves, not a summary on a form.
You send us what you have. The gaps are usually inside the documents, which is why a questionnaire cannot find them and a reading can.
Test reports prepared for CE marking or a domestic submission are worth sending even if you assume they do not count. Some of them do, and knowing which is a large part of the answer.
- Device description and specificationsDrawings and photographs too, if you have them.
- Existing test reportsIncluding any prepared for CE marking or a domestic submission.
- Current labeling and instructions for use
- Any predicate you have already identifiedIf you have one. Confirming yours is as useful a result as replacing it.
- Quality system documentationOnly to the extent it affects the submission. A full audit is separate work.
Send what you have. A document you cannot find is itself a finding, and the report names it alongside everything else.
A range is what an honest quote looks like before anyone reads your file.
The fixed price we quote afterwards comes straight from what the assessment finds, which is why we do not quote before it.
Your predicate
A close one narrows the file. A distant one widens every section of it.
Your claims
Which indications your existing evidence already supports, and which need work first.
Your scope
How many of your documents already meet FDA standard, and how many need drafting.
You own the report. All three of these are fine.
Where a requirement is not yet met, the report names it and sets out exactly what closes it. In our experience most companies complete that work in about three months and file on schedule.
Build it with us
We quote a fixed price from what the assessment found, and prepare the submission.
Take it elsewhere
File it yourself, or brief another consultant with it. It is your document and it is written to be used by anyone.
Decide not to proceed
A clear picture of the cost is a legitimate reason to stop. Finding that out now is cheaper than finding it out later.
Find out the size of the job before you commit to any of it.
- No charge
- A written report you keep
- A named predicate
- Sets your build price
At a glance
| What it is | A written comparison between what your device already has and what a 510(k) submission requires. |
|---|---|
| Who it is for | Companies that intend to file but do not yet know the size of the job. |
| What it decides | Where your 510(k) build sits in the $11,000 to $20,000 range. |
| What it is not | Not a submission, and not a guarantee of clearance. It is a decision document. |
| Turnaround | Returned before the build scope is set. |
| Fee | No charge. |
Questions people ask
How is this different from the free device check?
The free check returns your product code, class, whether a 510(k) is required, and three cleared devices in the category. The gap assessment examines your actual documents and tells you what closing the difference costs. The free check answers “do I need one”. This answers “what will it take”.
Can we use the report with another consultant?
Yes. It is your document and it is written to be used by anyone.
What if we already have a predicate in mind?
We assess it. Confirming a predicate that works is as useful a result as replacing one that does not, and it takes the same effort to check.
Do you need our quality system documents?
Only to the extent they affect the submission. A full quality system audit is separate work.
Why is it free?
Because the fixed price for the build is only honest once someone has read your documents. Quoting before that is guessing, and a guess that turns out low is a change order later. The assessment is what makes the number real, so we would rather do it first than argue about scope afterwards.
We do not have all of those documents yet. Should we wait?
No. Send what you have. A missing document is itself a finding, and the report names it alongside everything else you need. Waiting until the set is complete defeats the point of asking what is missing.