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Expert 510(k) Submission Services to Fast-Track Your FDA Clearance
Get your medical device FDA-cleared with complete confidence. At Elexes, we specialize in crafting accurate, compliant, and timely 510(k) submissions tailored to your device and market goals. Whether you're launching a new product or modifying an existing one, our team of regulatory experts will guide you through every step—from predicate selection and documentation to FDA eSTAR 510(k) assistance and post-submission support.
What is a 510(k) Submission? (FDA Premarket Notification Explained)
A 510(k) submission, also known as a premarket notification, is a regulatory filing submitted to the U.S. Food and Drug Administration (FDA) to demonstrate that a medical device is substantially equivalent to a legally marketed device (called a predicate). It is a critical pathway for most Class II medical devices and some Class I and III devices.
At Elexes, we guide you through the complete FDA 510(k) submission process—from identifying the right predicate and gathering required data to submitting the FDA's eSTAR-compatible application and responding to queries during review.
Who Needs a 510(k) Submission?
You will likely need a 510(k) submission if:
⦿ Your device is classified as Class II or in some cases Class I or Class III
⦿ You are introducing a new device with a predicate on the market
⦿ You are making significant changes to an existing cleared device (e.g., indications, technology)
Elexes will conduct a regulatory assessment to determine if a 510(k) is required and help you identify the most suitable predicate device to support your application.
Our end-to-end 510(k) submission services
We offer comprehensive 510(k) consulting services and submission services tailored to your device and business needs. Our offerings include:
Regulatory Strategy Development
Evaluate device classification, predicate identification, and determine submission type (Traditional 510(k), Special 510(k), or Abbreviated 510(k)
Technical Documentation Preparation
Prepare 510(k) Summary, Indications for Use, Device Description, Substantial Equivalence, Risk Analysis, and more.
Testing & Labeling Guidance
Assist with test protocol review, performance testing (bench, biocompatibility, electrical safety), and FDA-compliant labeling.
Submission & FDA Communication
Compile and eSubmit the 510(k) via the FDA’s eSTAR program. Address FDA inquiries and manage the interactive review process.
With Elexes, you’ll gain a reliable partner experienced with successful submissions across various therapeutic areas—imaging, orthopedic, dental, digital health, and more.
Why choose Elexes for Medical device 510(k) Clearance?
⦿ Unmatched Regulatory Expertise
Our team includes FDA Submission Experts and certified regulatory professionals who stay updated with the latest FDA guidelines.
⦿ Accelerated Time to Clearance
We optimize your submission to minimize review time and address FDA questions proactively.
⦿ Cross-Functional Support
From engineers to compliance specialists—we cover technical, clinical, and regulatory aspects.
⦿ Client-Centric Approach
Transparent communication, tailored strategies, and strict confidentiality.
Get expert guidance and reduce clearance time. Book Your Free Regulatory Consultation
Understanding Your 510(k) Pathway
Navigate your submission strategy with a quick comparison and step-by-step visual guide.
FDA 510(k) Decision-Making Flowchart
Understanding the FDA’s 510(k) process is key to a successful submission. Below are the core steps manufacturers must follow to demonstrate substantial equivalence:
⦿ Device Classification
Determine if your device is Class I, II, or III based on risk and intended use.
⦿ Prepare the 510(k)
Compile technical details, intended use, performance data, and predicate comparison.
⦿ Identify Predicate Device(s)
Select a legally marketed device with similar use and technology.
⦿ Submit to the FDA
Use FDA’s eSTAR format to submit complete documentation.
⦿ FDA Review
FDA assesses equivalence and may request additional information.
⦿ FDA Decision
If cleared, your device can be marketed. If not, explore other pathways like De Novo or PMA.
⦿ Post-Market Compliance
Meet ongoing requirements for safety, reporting, and surveillance.
For a visual overview, visit our full 510(k) Decision-Making Flowchart blog.
Quick Turn around
Experience timely results with our efficient services.
Confidentiality guaranteed
We offer 100% confidentiality understanding how critical the data is for you.
Elexes offer complete range of regulatory and compliance expertise, ensuring full-support in product development and post-market compliance. Get everything under one roof for your medical device!
Our New Product Approval Service Corner
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
Associated Regulatory Authorities.
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Clients Testimonials
Amazing Feedback About Our Services
Tom Birney
CEO Masterlink, Arizona
“
Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms
“
Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
“
Daniel Kinsey
President ViDava, Florida
“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice.
“
Linda Pan
Sr. Exe Treedental, Hong Kong
“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step.
“
Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
“
Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
“
Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations.
“
Samip Shah
VP Regulatory AliveCor, California
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.
“
Elizabeth W
Owner Liz Inc., Arizona
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.
“
Kurt Sysock
CEO Radformation, New York
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!
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