Experienced in different type of devices. Qualified and experienced team. Most economic among others

US FDA 510K

A 510k is a premarket submission made to FDA that demonstrates the device to be sold is as safe and effective, that is, substantially equivalent, to a legally marketed device. A technical file, known as 510(k), needs to be submitted to the FDA for devices meant to be used on humans.

A 510(k) submission must be made for devices that do not need a Premarket approval (PMA) and are not exempt from the 510(k) requirements by manufacturers of medium-risk medical devices or IVD who wish to market their devices in the U.S. The 510(k) submission or premarket submission includes technical, performance and safety information about the medical device.

Once 510(k) clearance is obtained from FDA, the manufacturer can legally market the medical device in US market.
Shorter review time (if the data submitted is accurate, the review time is about 90 days).
Most 510(k) submissions do not need clinical data.
Review fee is much lesser than that for PMA.

An FDA 510k is required for introducing most Class II medical devices, some Class I and Class III devices and IVDs in the U.S. market, a 510(k) submission needs to be made by

A U.S. manufacturer wishes to introduce a finished medical device.
A specification manufacturer develops the specifications for a device but manufactures the device under contract with another firm wish to introduce the device.
Re-packagers and re-labellers if a significant change is made in the labelling or if the device’s condition is affected.
Foreign manufacturers or exporters

The Premarket approval (PMA) is the regulatory pathway chosen for class III devices used to sustain/ support human life and present substantial risks. This method is used to prove the safety and performance of a new medical device using data obtained from laboratory testing and clinical trials with human participants in most cases.

How to approach FDA for FDA 510k Approval?

The medical device 510k process consists of the following steps:

Confirm the classification of the medical device and if the device needs 510(k).
Identify the product code, device classification and regulation number of the medical device based on its intended use.
Find a suitable predicate device that is substantially equivalent to the proposed device for the intended use, material composition, fundamental scientific technology, principles of operation, and basic design
Demonstrate that the proposed device is at least as safe and effective as the identified predicate device to prove the substantial equivalence to the predicate device
Prepare the 510(k) file
Make the 510(k) review fee payment and submit it to FDA

FDA will send a confirmation whether the submission is accepted for review in about 2 weeks. The evaluation of substantial equivalence by the FDA generally takes 90 days and is based on the information found on the data submitted. But, it may take longer if a Refuse-to-Accept or Additional Information letter is issued, the reply to which needs to be submitted within 180 days.

Once the review is completed successfully, a 510(k) clearance letter with a unique 510(k) number for the device will be sent by the US FDA, along with a copy of the device’s approved Indications for Use.

A 510(k) clearance is the status granted by the US FDA to a medical device at the end of the review of the premarket or 510(k) submission if the manufacturer can successfully establish that the device undergoing review is at least as safe and effective as the chosen predicate device. A clearance letter with a unique 510(k) number for the device along with a copy of the device’s approved Indications for Use will be sent by FDA once 510(k) clearance is obtained. The manufacturer can then legally market the device in the US.

How do I file a 510k with FDA?

To file the 510(k) submission with FDA, the following steps will have to be followed:

Confirm the classification of the medical device and if the device needs 510(k)
Find a suitable predicate device that is substantially equivalent to the proposed device.
If you have any queries and clarification are required, apply for the pre-submission program to obtain feedback from the FDA for a potential or planned medical device application before the actual 510(k) submission. The pre-submission process may take up to 120 days to complete
Once the competing 510(k) file is prepared, pay the 510(k) review fee and submit the file to FDA.
The evaluation of substantial equivalence by the FDA generally takes 90 days and is based on the information found on the data submitted.
It may take longer if a Refuse-to-Accept or Additional Information letter is issued, the reply to which needs to be submitted within 180 days.

FDA 510k Approval Process

service related FAQ’s

What Documents and how to submit 510k file?adminreg2025-07-30T09:38:17+05:30

What Documents and how to submit 510k file?

The 510(k) file includes documents used to establish the safety and efficiency of the proposed medical device through substantial equivalence. The documents included in the 510(k) file are:

Form FDA 3601: Medical Device User Fee Cover Sheet (MDUFC sheet)
FDA Form 3514- CDRH Premarket Review Submission Cover Sheet: This document includes basic administrative and device information.
510(k) Cover Letter: This document provides a brief idea about the purpose of the submission, device, manufacturer and the U.S agent (if any).
FDA Form 3881: Indications for Use Statement
510(k) Summary or 510(k) Statement: This includes a summary of the device undergoing the 510(k) clearance.
Truthful & Accuracy Statement: This is to certify that the 510(k) submission contents are truthful and accurate and no information omitted.
Class III Summary and Certification: If the proposed device is a Class III exempt from PMA, otherwise, this can be marked as not applicable.
Financial Certification or Disclosure Statement: This is applicable only if clinical studies were conducted
Declarations of Conformity and Summary Reports: Lists the voluntary consensus standards used and includes DOC to such standards.
Device Description: This document includes the description of the device design requirements and performance specifications.
Executive Summary: a brief description of the device & comparison table with the predicate device identified.
Substantial Equivalence Discussion: Detailed comparison between the proposed device and the predicate device chosen.
Proposed Labeling: Is discussed in detail to comply with 21 CFR 807.87(e) for general medical devices and 21 CFR 809.10 for IVD’s
Sterilization and Shelf Life: This document provides details regarding the sterilization and shelf life claim being made.
Biocompatibility: This document is applicable if the proposed device comes into direct or indirect contact with the human body tissue.
Software: This includes the documentation for any software used in the proposed device
Electromagnetic Compatibility and Electrical Safety- If the proposed device is powered electrically, in which case the EMC must be evaluated.
Performance Testing – Bench: This document included details of the bench tests performed to evaluate the efficiency of the proposed device.
Performance Testing – Animal: This document included details of the animal testing performed to evaluate the efficiency of the proposed device.
Performance Testing – Clinical: This document included details of the clinical studies performed to evaluate the efficiency of the proposed device.

The completed FDA 510(k) file is submitted in electronic format as an e-copy to the FDA. The submission package is sent to the CDRH through registered mail or commercial delivery service.

FDA Medical Device Classification

FDA 510k Premarket Notification

FDA Medical Device Registration and Listing

US FDA Consultants