A 510(k) is also referred to as a premarket notification, is one of the major pathways for bringing devices to the US market. The 510(k) is the most common premarket submission for medical devices.
510(k) application is based on the determination of Substantial Equivalence. Substantial Equivalence is basically the demonstration that your new device, compared to a predicate device, has the same intended use and the same technological characteristics, or it has the same intended use and the differences in technological characteristics do not raise different questions about safety and effectiveness. The predicate device is a legally marketed device which is approved by means of the 510(k) process and is utilized for comparison with your new device in relation to the predicate device.
What is 510(k) Clearance and Why Is It Required?
FDA 510(K) Clearance is an FDA decision on whether a device is substantially similar to an already marketed device. It involves a process that enables a device to get into commercial marketing in the United States via the 510(k) pre-market notification. The core concept behind FDA 510(K) Clearance is Substantial Equivalence. Only products or devices approved through the premarket approval process are considered FDA approved.
It is required in the United States because the FDA needs evidence that a new medical device is substantially equivalent to a legally marketed device (called a predicate device) before it can be commercially distributed.
Does Your Device Need a 510(k)?
You can easily find whether your device Need a 510(k) or not using Classification database. You can search by either product code or regulation number. FDA uses product codes which are three letter codes used to identify and track similar devices.
- First determine the appropriate FDA product code for your device, then easily determine the appropriate regulatory pathway
- Product codes can be found by searching the FDA’s public product classification database.
Devices Requiring 510(k) Clearance
Most, but not all, Class II devices require a premarket notification, and certain Class I requires 510(k) clearance.
Devices that fall under risk Class II devices and certain Class I devices that are not exempt from premarket notification requirement require 510(k)
FDA 510(k) Submission Step by step Process
The FDA oversees the approval process for medical devices in the US as per the Food, Drugs, and Cosmetics (FD&C) Act. Most devices are cleared using the 510(k) route, whereby the manufacturers must show substantial equivalence with an existing approved device.
- Step 1: Search for a Predicate Device (Device Class, Product Code, and CFR Regulation)
- Step 2: Preparation of 510(K) File
- Step 3-Payment of Fee
- Step 4: 510(K) Submission Process and Review
- Step 5: 510(K) Decision Letter
Types of 510(k) Submissions
Traditional 510(k)
The traditional 510(k) relies on the demonstration of Substantial Equivalence. It’s important to note that a traditional 510(k) can be used under any circumstance.
Special 510(k)
A special 510(k) is appropriate when you are making device modifications to a manufacturer’s own legally marketed device. Therefore, you are making modifications to your own product. It is important to note, also, for a special 510(k) to be appropriate; the modification may not affect the intended use or the fundamental scientific technology of the device.
Abbreviated 510(k)
An abbreviated 510(k) relies on the use of guidance documents, special controls and recognized standards. Under certain conditions, sponsors may not need to submit test data in an abbreviated 510(k) because you are following the FDA recommendations and guidance documents or recognized consent of standards. So, that is when an abbreviated 510(k) may be appropriate.
FDA eSTAR Submission Process
All 510(k) submissions must be submitted as electronic submissions using eSTAR.
After the completion of the eSTAR submission, the top status of the message in the eSTAR template will state “eSTAR COMPLETE.” In case you submit an incomplete eSTAR submission by the time the status message is showing “eSTAR INCOMPLETE,” then it will not be accepted by the CDRH Portal. An incomplete eSTAR submitted by mail or ESG will be placed on hold for up to 180 days.
For CDRH, send eSTAR premarket submissions online through the CDRH Portal:
Send and Track Medical Device Premarket Submissions Online to CDRH Portal
Note: 510(k) submissions must be submitted using the CDRH Portal. If your submission exceeds file size limitations, see the CDRH Portal page for further instructions.
510(k) Documentation Requirements
- Medical Device User Fee Cover Sheet (Form FDA 3601)
- CDRH Premarket Review Submission Cover Sheet
- 510(k) Cover Letter
- Indications for Use Statement
- 510(k) Summary or 510(k) Statement
- Truthful and Accuracy Statement
- Class III Summary and Certification
- Financial Certification or Disclosure Statement
- Declarations of Conformity and Guidance Documents
- Executive Summary
- Device Description
- Substantial Equivalence Discussion
- Proposed Labeling
- Sterilization and Shelf Life
- Biocompatibility
- Software
- Electromagnetic Compatibility and Electrical Safety
- Performance Testing – Bench
- Performance Testing – Animal
- Performance Testing – Clinical
- Other
FDA Pre-Submission (Q-Sub) Process
FDA Pre-Submission (Q-Sub) is a valuable program and Meetings with the FDA Staff. It is a way to obtain feedback from the FDA before the actual submission of your 510(k).
But typically, a pre-sub for a 510(k) is only appropriate for unique situations, such as when you may need clinical data to support your demonstration of substantial equivalence. Through the pre-submission program, you would submit a formal written request to the FDA, and you would request a formal written response, a meeting, or a teleconference to address your concerns. Because this is a formal written request, it is subject to e-copy requirements, which we’ll discuss during the submission of a 510(k).
How to Choose a Predicate Device for 510(k)
The 510(k) database has all the devices which are cleared under the 510(k) process. The FDA databases on the web are updated on or around the 5th of every month. The classification of the device and product code is essential in searching for predicate devices. The classification database will provide the classification panel (e.g., orthopedic devices), common name, product code, and CFR regulation.
Information which can be useful to find a predicate device includes:
- names of similar devices – traded name under which the device is marketed;
- manufacturer(s) of the similar device(s);
- marketing status, i.e., preamendments or postamendments device;
- 510(k) numbers for post amendments devices;
- classification information, i.e., product codes, classifying regulations, etc., for your device.
Once you have found the classification of your device, you should begin your search in the 510(k) database.
It is usually best to complete only one box in the online search form per search. The search engine searches for an exact match of text. Therefore, one descriptive word in the “device name” box is recommended.
FDA assigns a unique 3-letter product code for each generic category of device. Only FDA generated product codes will work with the 510(k) and other FDA databases. For similar device types, 510(k)s are generally linked in the 510(k) database through the same product code. If you know the name of the manufacturer for a similar device, then you can conduct a search on the database through that name. If there are no results found by you, then you can try out variations of the name of the manufacturer, because spaces or hyphenations can sometimes affect the result.
Manufacturers need to find the primary predicate device which has a similarity with the device under review. Manufacturers must identify a primary predicate device which is most like the device under review with respect to indications for use and technological characteristics. Manufacturers may identify more than one predicate device to help demonstrate substantial equivalence in certain circumstances. The use of split predicates is inconsistent with the 510(k) regulatory standard. Manufacturers may identify “reference devices” within 510(k) to support scientific methodology or standard reference values.
Fees of 510(k) Submission
Fees for Fiscal Year 2026 (October 1, 2025 to September 30, 2026) are:
| Application Type | Standard Fee | Small Business Fee |
| 510(k) | $26,067 | $6,517 |
Average review period for 510(k) clearance
After the FDA receives an eSTAR submission, given that a properly prepared electronic submission should represent a complete submission, eSTAR submissions are not anticipated to undergo a Refuse to Accept (RTA) process. However, the FDA intends to employ a virus scanning and technical screening process for eSTAR.
The technical screening process is anticipated to occur within 15 days of FDA receiving the 510(k) eSTAR. FDA intends to only begin the technical screening for 510(k) electronic submissions where the appropriate user fee has been paid. If the eSTAR does not pass technical screening, FDA will notify the submitter via email20 and identify the incomplete information, and the 510(k) will be placed and remain on hold until a complete replacement eSTAR is submitted to FDA.
If a replacement eSTAR is not received within 180 days of the date of technical screening deficiency notification, FDA will consider the 510(k) to be withdrawn and the submission will be closed in the system.
The technical screening review time does not impact the review clock for files that pass the technical screening. For a submission that passes technical screening, the review clock starts on the day the submission was received by FDA.
Reasons for 510k delays or rejection
Inconsistent Documentation: The intended use statement is often put into sections of the 510(k) in a way that does not match. It is crucial to know the difference between indications for use and intended use.
Inadequate Testing: The FDA usually does not accept incomplete verification and validation evidence. Submission dossiers should include test protocols, results, and reports to show that testing was done properly.
Lack of Stability Studies: The FDA wants proof to support claims of shelf life. Manufacturers should provide scientifically valid accelerated aging data, along with real-time aging data. Shelf life is about what happens to your product over time.
Wrong Predicate Selection: Choosing a predicate with a fundamentally different intended use or technological characteristics, which raises new safety questions, often results in a “Not Substantially Equivalent” (NSE) decision
eSTAR Technical Screening: Submissions utilizing the FDA’s electronic submission template (eSTAR) must be administratively complete. Missing forms, outdated templates, or incomplete sections will trigger an immediate hold.
FAQs
Can a company market a device without 510(k) clearance?
Yes, if a device falls under 510k exempt category then a company can market a device without 510(k) clearance
How often is 510(k) rejected by the FDA?
Most properly prepared 510(k) submissions are ultimately cleared after one or more rounds of questions and responses. NSE decisions are relatively uncommon compared with SE decisions, especially when an appropriate predicate device has been selected, and sufficient supporting data is provided.
How to Select a Predicate Device for 510(k) Submission?
To select a predicate device, need to lookout for the similar intended use and technological charcteristics as of that of the new device
Is 510k the same as FDA approval?
No, The FDA clears 510(k)s. The main principle of clearance is based on the determination of Substantial Equivalence. Only devices approved through the premarket approval process are considered FDA approved.
Who needs to submit a 510k?
Companies who would like to bring a medical device to the US Market which falls under 510(k) pathway can submit the application to the US FDA.
What is substantial equivalence?
Substantial equivalence means that a new medical device has same intended use as another legally marketed medical device (predicate device) and either:
- Has the same technological characteristics, or
- Has different technological characteristics that do not raise new questions of safety and effectiveness and can be shown to be at least as safe and effective as the predicate device.
Can foreign manufacturers submit 510(k)?
Yes. Foreign manufacturers can submit a 510(k). But foreign manufacturers need to appoint a US Agent who will communicate to the FDA for them.
What happens after FDA 510(k) clearance?
After receiving 510(k) clearance, the manufacturer can legally market the device in the United States. The manufacturer must also:
- Register for the manufacturing establishment with the FDA.
- List the cleared device with the FDA.
- Require complying with Quality System Regulation (QSR)
- Need to follow labelling, Medical Device Reporting (MDR), and post-market surveillance requirements, if necessary.
What is the difference between 510(k) and PMA?
| 510(k) |
PMA (Premarket Approval)
|
| Demonstrates substantial equivalence to a predicate device |
Demonstrates safety and effectiveness through valid scientific evidence
|
| Typically used for most Class II devices |
Typically required for Class III, high-risk devices
|
| Generally, less costly and faster |
More complex, costly, and time-consuming
|
| May not require clinical data |
Often requires clinical data
|
| Results in FDA clearance |
Results in FDA approval
|
What devices are exempt from 510(k)?
Some class I and II devices are exempted from premarket notification (510(k)) requirement. As these devices are subject to regulatory controls.
