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Send what you already have
Specs, intended use, test reports, IFU drafts. Any format. Complizen reads all of it into a structured device profile, so nothing has to be re-typed into a form first.
510(k) submission
510(k) Submission
The whole file, built and filed for you — every section drafted, then reviewed and signed by a named regulatory expert.
A 510(k) is one argument supported by a stack of evidence. What you are buying is somebody who has made that argument before, working in a platform that has already read the guidance for your product code.
$11,000 to $20,000
Fixed the moment your scope is agreed. No hourly billing, and FDA’s Additional Information round is inside the fee rather than billed on top of it.
- Our fee
- $11,000 to $20,000
- Billing
- Fixed once scoped
- FDA's fee
- $28,653, or $7,163
- You receive
- The assembled eSTAR
- FDA's questions
- Answered in the fee
- Who files
- We do, in your name
What you receive
One submission file. These are its nine parts.
Not a folder of documents you assemble yourself. The eSTAR is FDA’s own template, and what we hand over is that file, complete.
Cover letter and FDA forms
Completed, in the order the eSTAR expects to receive them.
Device description
With drawings and photographs, written for a reviewer who has never seen your device.
The substantial equivalence argument
Characteristic by characteristic against the predicate, with the K-number behind it.
Performance testing
Organised in the order FDA reads it, each report tied to the claim it supports.
Biocompatibility
Or a documented justification for why it is not required for your device.
Software documentation
At the documentation level your device's risk actually calls for, and no higher.
Sterility and shelf life
If your device is supplied sterile, with the validation behind both.
Labeling
Checked against Part 801 before FDA sees it, not after.
The assembled eSTAR
Compiled into the single file FDA receives, and filed in your name.
The argument
A 510(k) does not claim your device is the same.
It claims the device is substantially equivalent to one FDA has already cleared. Your device may use different materials, a different mechanism and different software and still qualify — provided the differences raise no new question of safety or effectiveness, and you have the data to show it.
Which is why the predicate is chosen first and agreed with you before a word is drafted. It sets what has to be argued and what has to be tested, and a Not Substantially Equivalent decision almost always traces back to that one choice rather than to anything in the writing.
You see the K-numbers and the reasoning, including for the candidates we rejected, in the gap assessment — so nothing is chosen on your behalf without your sign-off.
Substantial equivalenceYour device against the predicate
- Intended useMust match
A different intended use is a different device. This is the one line where a difference ends the argument before it starts — and it is why a claim added late can cost more than a component change.
- Technological characteristicsMay differ
A different mechanism, a different design, different software. All permitted, provided the difference raises no new question of safety or effectiveness.
- Materials in patient contactMay differ
With biocompatibility evidence covering the materials you actually use, rather than the ones the predicate used.
- PerformanceMay differ
Where your device performs differently, the bench data has to show the difference does not change what the device does for the patient.
That is the whole submission in one sentence: not identical, but raising no new question of safety or effectiveness. Every other section of the file exists to support it.
How it works
Five steps from your documents to a filed submission.
One workspace. Your team and ours, from the first upload to FDA's decision — and the drafting is done by a platform that has already read the guidance for your product code.
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The submission, mapped before it is written
Your file is mapped against the current eSTAR template — every section, every dependency, and every piece of evidence still outstanding. You and your regulatory expert are in the same workspace from day one.
03
Every section drafted, with the citation under it
Each section is drafted from your device profile, your predicate and the guidance that applies to your product code — with the source under every claim, so a reviewer can check it and so can you.
04
A named expert reviews and signs
A regulatory affairs professional reviews every section as it is drafted. Inline comments, tracked changes, sign-off — all of it visible to your team while it happens, not summarised afterwards.
05
Compiled, filed, and held to the decision
Your eSTAR is assembled into the file FDA receives and submitted in your name. We stay on it through screening, through the review, and through anything FDA sends back.
Want to walk through your specific device first? We will tell you what the submission would involve, and whether you need one at all. No commitment.
Talk to an expertWhere the time actually goes
Ninety FDA days is not ninety days on your calendar.
FDA’s goal is a decision in 90 FDA days. An Additional Information request stops that count, and it does not restart until your response arrives.
What FDA counts90 FDA days
What your calendar counts90 FDA days, plus every day the clock is stopped
- FDA is reading. Counts against the 90.
- On hold while you answer. Counts against nothing but your calendar.
How complete the file was
Most Additional Information requests ask something the file could have answered. Fewer questions, fewer stopped days.
How fast the response is written
You have up to 180 days to answer. Nothing restarts until you do, so every day spent drafting is a day on your calendar.
Whether a second round opens
An incomplete answer buys another request. That is where a schedule slips from weeks into quarters.
FDA’s own fee
A quarter of the fee, if you ask before you file.
If your global sales, including affiliates, are under $100 million, you qualify for the small business rate. Applying is free. Almost nobody applies in time.
What FDA charges$28,653
With a Small Business Determination$7,163
$21,490not paid, on one submission
What it costs
$11,000 to $20,000, and four things that cannot move after you sign.
Where you land in that range depends on your predicate, the evidence you already hold, and how many sections need drafting from nothing. The free gap assessment turns the range into your figure before you commit to any of it.
The price
Fixed the moment scope is agreed. No hourly meter, and no revised estimate once we have started.
Fixed feeThe predicate
Agreed with you, with the K-numbers and the reasoning behind each, before a word of the file is drafted.
You sign it offThe FDA response
The Additional Information round is inside the fee. Answering it is where a fast clearance is usually won, and it is not the moment to be reading an invoice.
IncludedYour contact
One named regulatory expert, on the file from the predicate to the decision, dealing with FDA throughout.
To the decision
A named predicate, a defined scope, and a price that does not move.
- $11,000 to $20,000
- Fixed once scoped
- FDA's questions included
- Filed in your name
At a glance
| What it is | A complete 510(k) submission, drafted, reviewed by a named regulatory expert, assembled into FDA's eSTAR and filed. |
|---|---|
| Who it is for | Companies whose device needs a 510(k) and who would rather buy the file than build a regulatory department to produce it. |
| Our fee | $11,000 to $20,000, fixed once scope is agreed. |
| What sets your number | How close your predicate is, how much valid evidence you already hold, and how many sections need drafting from nothing. The gap assessment settles all three, at no charge, before we quote. |
| Not included | Laboratory testing, and FDA's own user fee. You see the cost of any testing before it is ordered. |
| FDA's own fee | $28,653 from 1 October 2026, or $7,163 with a Small Business Determination. Paid straight to FDA, not to us. |
| The clock | FDA's goal is 90 FDA days. An Additional Information request stops that count until your response arrives, so the calendar runs longer than the clock. |
| Where to start | The free device check if you are not yet certain, the gap assessment if you are. Both free. |
| If your device is exempt | Then there is nothing to file, and we will tell you so. Your path is establishment registration and a device listing instead. |
Questions people ask
How long does a 510(k) actually take?
FDA's goal is a decision in 90 FDA days, and FDA days are not calendar days. An Additional Information request stops the count and it does not restart until your response arrives, so the honest answer is that the calendar depends on how complete the file is and how fast the response is written. Both of those are ours, which is why we quote a submission date rather than a clearance date.
What happens if FDA comes back with questions?
An Additional Information request is a normal part of a 510(k), not a failure. We draft the response, you approve it, and it is inside the fixed fee — not a change order and not billed by the hour while the review is on hold.
Do you guarantee clearance?
No, and nobody honestly can — FDA decides. What we can tell you before you spend anything is whether the predicate and the evidence support the argument, which is what the free gap assessment is for. If it does not, we would rather say so than sell you a submission.
Can you use the test reports we already have?
Often, yes. We check your existing reports against the standards FDA recognizes before you commission anything new. Reusing valid data is usually the largest single saving available in a submission, and reports prepared for CE marking are worth sending even if you assume they do not count.
What is not included in the fee?
Laboratory testing and FDA's own user fee. You will know exactly what testing is required and what it costs before anything is ordered, and nothing is commissioned without your decision.
How much does a 510(k) cost in total?
Three lines, and only the first is ours. Our fee is $11,000 to $20,000, fixed once scope is agreed. FDA's user fee is $28,653, or $7,163 with a Small Business Determination. Laboratory testing is whatever your device still needs, which is exactly what the free gap assessment goes and finds out before anyone quotes you a total.
How is this different from hiring a consultant by the hour?
The meter. An hourly engagement bills you for the Additional Information round, for the second one if it comes, and for every hour spent on a predicate that turns out not to work. Ours is one number agreed before the work starts, and the responses are inside it — so the incentive to get the file right the first time sits with us rather than with you.
We already started a submission. Can you take it over?
Usually, yes, and it is worth asking early. A file already with FDA, an Additional Information request nobody can answer, or a draft that stalled — all of them are things we pick up. We read what exists first and tell you whether it is worth continuing or worth restarting, which is not always the answer that suits us.
Who talks to FDA during the review?
We do, on your behalf. You see every message in both directions, and nothing is sent without your approval.
What happens if FDA asks for data we do not have?
We tell you exactly what is required and what it will cost before anything is ordered. You decide whether to proceed.
Do we need a company in the United States?
No. You need a US Agent, and we can act as yours.
Who will the clearance belong to?
You. Your company is the applicant and the K-number is issued in your name.
What if our device turns out to be exempt?
Then you do not need this service and we will say so. The check that establishes it is free, and your path is a registration and a listing rather than a submission.
“We had years of CE experience, but FDA is a different system. Complizen guided us through every step, and our first US clearance was far easier than we expected.”
Özgür Güler
CEO, PMS Healthcare Technologies
Two ways to build your submission
Prefer to build it yourself?
Self-serve
Submission Builder
Plans from
$499
per month, billed annually
Draft your own eSTAR on the platform our experts use — device-specific, section by section, with the same datasets behind it. No expert review and no filing on your behalf.
- Device-specific eSTAR drafting
- Same regulatory datasets
- Superagent
- Citations under every claim
- No expert review
- No filing on your behalf
Expert-led
510(k) Submission Building
From
$11,000
Fixed fee, once scoped
Or have us do it. A regulatory affairs professional with 10 to 25 years of direct 510(k) experience builds and signs the file, supported by the same platform.
- Predicate analysis and sign-off
- Every section drafted and reviewed
- Additional Information responses
- Filed with FDA in your name