From October 1, 2026, FDA charges $28,653 to review a 510(k), or $7,163 if you qualify as a small business. Your total cost is higher, because testing, preparing the submission, US registration and months of review time all add to the bill.
Key takeaways
- The FDA fee is the same for a Traditional, Special or Abbreviated 510(k): $28,653, or $7,163 for a business with gross receipts of $100 million or less.
- FDA estimates about 79 hours to prepare a 510(k), plus 40 hours to format it in eSTAR. That covers the paperwork only, not testing.
- By our count, the median 510(k) cleared in 2025 took 126 calendar days from FDA receipt to decision. A Special 510(k) took a median of 30.
- In 2025, Traditional 510(k)s from Korean applicants took a median 170 days, and from Taiwanese applicants 197, against 134 for US applicants.
- About half of all 510(k)s are eligible for Third Party Review, which carries no FDA fee. Only 60 of the 3,198 cleared in 2025 used it.
How much does FDA charge for a 510(k)?
FDA's standard 510(k) fee is $28,653 from October 1, 2026, the start of fiscal year 2027 [1]. A business whose gross receipts or sales, including affiliates, are $100 million or less can qualify for the small business fee of $7,163 [1].
The fee does not change with the type of 510(k). Traditional, Special and Abbreviated 510(k)s all carry the same user fee [2]. If you are new to the process, our 510(k) guide explains each step.
Every establishment that makes devices for the US market also pays an annual registration fee. It is $13,785 from October 1, 2026 [1]. This is separate from the 510(k) fee and recurs every year.
Our FDA user fees page lists every current rate, the refund rules and how a company outside the US applies for small business status. To see your own fee, use the free 510(k) fee calculator.
What goes into the total cost of a 510(k)?
The FDA fee is the only fixed price in a 510(k). Everything else depends on your device, your predicate and how complete your file is when you submit it. This table shows each part of the budget and what drives it.
| Budget line | What drives the cost | Who you pay |
|---|---|---|
| FDA 510(k) fee | Fixed; lower with small business status | FDA |
| Testing | Your device's regulation, special controls and recognized standards | Test laboratories |
| Preparing the submission | How strong your predicate is and how complete your data is | Your team or a consultant |
| Answering FDA's questions | How many Additional Information requests you receive | Your team or a consultant |
| Establishment registration | Fixed yearly fee | FDA |
| US Agent | Required for every establishment outside the US | Your US Agent |
| Quality system | 21 CFR Part 820 applies to most devices | Your own operations |
| Third Party Review (optional) | Replaces the FDA fee with the review organization's price | A review organization |
| Pre-Submission (optional) | No FDA fee on the fee schedule | Nobody, in FDA fees |
FDA publishes its own estimate of the preparation work. In a notice dated July 22, 2026, FDA estimates 79.25 hours to prepare a 510(k) submission and 40 hours to put it into the eSTAR format [5]. Use these figures to budget your team's time on the document itself.
That estimate excludes the expensive parts. It covers preparing the paperwork, not running tests, fixing design gaps or answering FDA's questions. Testing depends on your product code, so start there. Our guide to FDA medical device classification shows how to read your product code and find the rules that set your test plan. For the wider budget, including design and development, see our guide to medical device development costs.
Two lines apply to companies outside the US in particular. Every foreign establishment must name a US Agent under 21 CFR 807.40 [10]. And the quality system rule in 21 CFR Part 820 applies to most devices, including most Class I devices exempt from 510(k) [6, 11]. Our US Agent guide explains what the role involves.
What does a real 510(k) budget look like?
Here are the fixed facts behind two real 510(k) budgets: a nitrile examination glove, a common export from Malaysia, and a root-form dental implant, a common one from Korea. Each row comes from FDA's own records.
| Budget fact | Nitrile exam glove (LZA) | Dental implant (DZE) |
|---|---|---|
| FDA 510(k) fee | $28,653, or $7,163 small business | $28,653, or $7,163 small business |
| Class | Class I | Class II, with a special controls guidance |
| Recognized standards FDA lists | 13, including ASTM D6319 and ASTM D5151 | 12, including ISO 14801 and ISO 7405 |
| Third Party Review | Eligible | Not eligible |
| 510(k)s cleared in 2025 | 24 | 31 |
| Median calendar days in 2025 | 110 | 184 |
| US Agent, for a manufacturer outside the US | Required | Required |
Source: FDA Product Classification database entries for LZA and DZE, checked September 24, 2026 [13]; our count of 2025 clearances via openFDA [6]. These are small numbers, so treat the medians as a guide.
The glove's test plan starts from its standards list. FDA lists 13 recognized standards for this product code, including ASTM D6319 for nitrile examination gloves and ASTM D5151 for detecting holes [13]. Send that list to laboratories and ask them to quote against it. The glove is also eligible for Third Party Review, yet none of the 24 glove 510(k)s cleared in 2025 used it [6]. If you manufacture in Malaysia, our guide on whether an MDA registration helps with FDA clearance covers what transfers.
The implant's test plan starts from FDA's guidance. FDA's special controls guidance for root-form dental implants sets out what the submission must address, alongside 12 recognized standards such as ISO 14801 for fatigue testing [13, 14]. The code is not eligible for Third Party Review, and in 2025 the median clearance took 184 days, so budget for a longer review.
How long does a 510(k) take, and why does time cost money?
We analyzed every 510(k) that FDA cleared in 2025: 3,198 decisions from FDA's public records [6]. The median took 126 calendar days from FDA receipt to decision. The middle half took between 79 and 213 days, and 67 took more than a year.
| 510(k) type | Cleared in 2025 | Median calendar days | Middle half |
|---|---|---|---|
| Traditional | 2,655 | 142 | 90 to 231 |
| Special | 481 | 30 | 27 to 57 |
| Abbreviated | 41 | 154 | 89 to 265 |
Source: our count of FDA 510(k) decisions dated January 1 to December 31, 2025, via openFDA [6].
FDA's goal is shorter than these numbers, for a reason. FDA aims to decide 95% of 510(k)s within 90 FDA days [7]. FDA days pause whenever FDA waits for you to answer its questions. Calendar days keep running. That gap is where much of the real time goes. FDA's own report to Congress for fiscal year 2025 says the same: FDA met its 510(k) review goals, but time on hold increased total review time [16]. So budget for at least one round of Additional Information questions.
Additional Information requests carry a hard deadline. FDA gives you 180 calendar days to respond. If FDA does not receive a complete response in that time, it treats the 510(k) as withdrawn [8]. You would then need to file again.
Put a price on the wait. Take the gross profit you expect from one month of US sales, then multiply it by the months of review you are planning for. That is what each month of delay costs you. In 2025, the median Special 510(k) took 112 fewer days than the median Traditional one, so use the Special route wherever it applies [6].
Does a 510(k) take longer if you file from outside the US?
In 2025, it often did. Traditional 510(k)s from Korean applicants took a median 170 calendar days, and from Taiwanese applicants 197, against 134 for US applicants [6].
| Applicant country | Traditional 510(k)s cleared in 2025 | Median calendar days | Took over 180 days |
|---|---|---|---|
| United States | 1,208 | 134 | 34% |
| South Korea | 130 | 170 | 46% |
| Taiwan | 57 | 197 | 58% |
| Japan | 79 | 121 | 29% |
| Germany | 93 | 203 | 57% |
Source: our count of FDA 510(k) decisions in 2025, Traditional submissions only, via openFDA [6].
The data shows the gap, not the cause. Calendar time includes the days a submission sits on hold while the applicant answers FDA's questions. Japan came in faster than the US, and Germany slower than Korea, so distance alone does not explain it. India, Malaysia and Turkey had too few 2025 clearances to compare reliably.
What you control is your response time. Have your test reports, translations and technical staff ready before you file. When an Additional Information request arrives, answer it completely the first time. If you manufacture in Korea, our guide on what transfers from an MFDS licence covers the evidence side. For Taiwan, see what transfers from a TFDA licence.
When does each cost hit your budget?
The costs arrive in stages, and the largest payments come before FDA sees your file. This order helps you plan cash flow.
- Before you file: testing, preparing the submission and, if you want one, a Pre-Submission, which carries no FDA fee.
- When you file: the FDA 510(k) fee. FDA must receive the correct fee when you submit, or it will not accept the file for review [1]. The fee year is set by the later of the date FDA receives your file and the date the US Treasury recognizes your payment [1]. So a file sent just before October 1 can fall under the new fee if the payment clears late.
- During review: answering FDA's questions, within 180 days of each Additional Information request [8].
- When you are ready to ship: establishment registration, device listing and a named US Agent. A foreign establishment registers for devices that are imported or offered for import into the US [10], and a device that needed a 510(k) is listed with its 510(k) number [15].
- Every year after that: the establishment registration fee renews annually [1].
Which choices lower the cost of a 510(k)?
Five choices change what you pay or how long you wait. None of them lowers the standard of evidence FDA expects.
Qualify as a small business. It cuts the FDA fee from $28,653 to $7,163 if your gross receipts are $100 million or less [1]. Companies outside the US can qualify, but the paperwork takes time, so start early.
Check whether Third Party Review fits. About half of the 510(k)s FDA receives are eligible [4]. You pay the review organization instead of FDA, with no separate FDA user fee, and FDA decides within 30 days of receiving the organization's recommendation [4]. Yet by our count, only 60 of the 3,198 510(k)s cleared in 2025 used this route [6]. Our Third Party Review guide explains how to check eligibility.
Use a Special 510(k) for changes to your own device. FDA intends to process a Special 510(k) within 30 days of receipt [3]. In 2025, the median Special 510(k) took 30 calendar days [6]. The fee is the same, but the wait is far shorter.
Ask FDA before you test. A Pre-Submission lets you get FDA's feedback on your predicate and test plan before you pay a laboratory. FDA's fee schedule lists no fee for it [1]. Our Q-Submission guide covers how to prepare one.
Submit a complete, defensible file. A weak predicate or a gap in your data leads to Additional Information requests, and each one adds time. Complizen's Superagent includes workflows for finding a defensible predicate and for responding to an FDA Additional Information letter. Since October 1, 2023, FDA has required 510(k) submissions to use the eSTAR format [12], and it runs a technical screening on each file before review begins [9]. Complizen's Submission Builder runs a pre-flight completeness check before you file.
What budget mistakes cost manufacturers the most?
The most common mistake is budgeting only for the FDA fee. The fee is fixed and public, so it gets planned. Testing, preparation and time are harder to see, and they drive the total.
Testing before you lock your predicate. Your predicate and product code decide which tests FDA expects. Test first and you may pay for work you cannot use.
Assuming a Class I device is cheap. 155 Class I product codes still need a 510(k), and most Class I devices still fall under the quality system rule [6, 11].
Letting an Additional Information request run late. After 180 days without a complete response, FDA treats the 510(k) as withdrawn [8]. Our FDA user fees page explains what happens to your fee when a 510(k) is withdrawn or refused.
Frequently asked questions
How much does a 510(k) cost in 2026?
FDA's 510(k) user fee is $28,653 from October 1, 2026, or $7,163 for a qualifying small business. Your total also includes testing, submission preparation, the annual establishment registration fee and your team's time, which vary with your device, your predicate and how complete your file is.
What is the FDA 510(k) fee for a small business?
The small business 510(k) fee is $7,163 from October 1, 2026, against $28,653 for the standard fee. To qualify, your business and its affiliates must have gross receipts or sales of $100 million or less. Companies outside the US can qualify, but the process takes time.
Is the fee the same for a Special or Abbreviated 510(k)?
Yes. FDA charges the same user fee for Traditional, Special and Abbreviated 510(k)s. The Special 510(k) saves time rather than money: FDA intends to process one within 30 days, and in 2025 the median Special 510(k) took 30 calendar days.
How long does it take to get 510(k) clearance?
In 2025, the median 510(k) took 126 calendar days from FDA receipt to decision, and the middle half took 79 to 213 days. FDA's goal is 90 FDA days for 95% of 510(k)s, but FDA days pause while FDA waits for your answers.
Do companies outside the US pay more for a 510(k)?
FDA's fees are the same wherever you are based. Companies outside the US must also name a US Agent, and in 2025 Traditional 510(k)s from Korean and Taiwanese applicants took a median 170 and 197 days, against 134 for US applicants.
How many hours does it take to prepare a 510(k)?
FDA estimates 79.25 hours to prepare a 510(k) submission, plus 40 hours to put it into the eSTAR format. That estimate covers the paperwork only. It does not include testing, design work or the time you spend answering FDA's questions during review.
Is a Pre-Submission free?
FDA's user fee schedule lists no fee for a Pre-Submission. You still spend your own team's time preparing questions and supporting information, but you can get FDA's feedback on your predicate and test plan before you pay for laboratory work.
Does Third Party Review cost less than going directly to FDA?
It replaces the FDA user fee with the review organization's own price, so compare quotes. FDA says about half of all 510(k)s are eligible, and FDA decides within 30 days of receiving the organization's recommendation. Only 60 of the 3,198 510(k)s cleared in 2025 used it.
What happens if I cannot answer FDA's questions in time?
FDA gives you 180 calendar days to respond to an Additional Information request. If FDA does not receive a complete response in that time, it treats your 510(k) as withdrawn, and you would need to file a new 510(k) to continue.
When do I pay the establishment registration fee?
You pay it when you register, which a foreign establishment does for devices imported or offered for import into the US, usually once you are ready to ship. It then renews every year. The fee is $13,785 from October 1, 2026, separate from the 510(k) fee.
What drives the cost of 510(k) testing?
Your device's product code does. It points to a regulation, any special controls and the recognized standards FDA expects you to meet. FDA lists 13 recognized standards for nitrile exam gloves and 12 for root-form dental implants, so confirm your product code before asking laboratories for quotes.
Is a Class I device cheaper to bring to market?
Often, but not always. Most Class I product codes are exempt from 510(k), so you avoid the 510(k) fee. But 155 Class I product codes still require one, and most Class I devices remain subject to FDA's quality system rule.
References
- Federal Register. Medical Device User Fee Rates for Fiscal Year 2027, 91 FR 48134. Published July 30, 2026.
- FDA. 510(k) Submission Programs. Accessed September 24, 2026.
- FDA. How to Prepare a Special 510(k). Accessed September 24, 2026.
- FDA. 510(k) Third Party Review Program. Content current as of November 20, 2024.
- Federal Register. Agency Information Collection Activities; Premarket Notifications Submission. Published July 22, 2026.
- openFDA. Device API: 510(k) and classification endpoints. 2025 decisions pulled September 24, 2026.
- FDA. MDUFA Performance Goals and Procedures, Fiscal Years 2023 Through 2027 (MDUFA V commitment letter).
- FDA. FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals. Guidance issued October 3, 2022.
- FDA. eSTAR Program. Accessed September 24, 2026.
- eCFR. 21 CFR 807.40, Registration and listing of foreign establishments. Accessed September 24, 2026.
- eCFR. 21 CFR Part 820, Quality Management System Regulation. Accessed September 24, 2026.
- FDA. Electronic Submission Template for Medical Device 510(k) Submissions. Final guidance, October 2023.
- FDA. Product Classification Database, entries for product codes LZA and DZE. Checked September 24, 2026.
- FDA. Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.
- FDA. Device Registration and Listing. Accessed September 24, 2026.
- FDA. FY 2025 MDUFA Performance Report to Congress.